Secondary standards laboratories for ionizing radiation calibrations: The national laboratory interests

NASA Astrophysics Data System (ADS)

Roberson, P. I.; Campbell, G. W.

1984-11-01

The national laboratories are probable candidates to serve as secondary standards laboratories for the federal sector. Representatives of the major Department of Energy laboratories were polled concerning attitudes toward a secondary laboratory structure. Generally, the need for secondary laboratories was recognized and the development of such a program was encouraged. The secondary laboratories should be reviewed and inspected by the National Bureau of Standards. They should offer all of the essential, and preferably additional, calibration services in the field of radiological health protection. The selection of secondary laboratories should be based on economic and geographic criteria and/or be voluntary.

Use of L-Glutamic Acid in a New Enrichment Broth (R-TATP Broth) for Detecting the Presence or Absence of Molds in Raw Ingredients/Personal Care Product Formulations by Using an ATP Bioluminescence Assay.

PubMed

Yang, Youjun; English, Donald J

The present study reports the effects of adding L-glutamic acid to a new enrichment broth designated as R-TATP broth, to promote the growth of slow-growing mold microorganisms such as Aspergillus brasiliensis and Aspergillus oryzae , without interfering in the growth of other types of microorganisms. This L-glutamic acid containing enrichment broth would be particularly valuable in a rapid microbial detection assay such as an adenosine triphosphate (ATP) bioluminescence assay. By using this new enrichment broth, the amount of ATP (represented as relative light unit ratio after normalized with the negative test control) from mold growth was significantly increased by reducing the time of detection of microbial contamination in a raw ingredient or personal care product formulation from an incubation period of 48-18 h. By using L-glutamic acid in this enrichment broth, the lag phase of the mold growth cycle was shortened. In response to various concentrations of L-glutamic acid in R-TATP broth, there was an increased amount of ATP that had been produced by mold metabolism in an ATP bioluminescence assay. By using L-glutamic acid in R-TATP broth in an ATP bioluminescence assay, the presence of mold could be detected in 18 h as well as other types of microorganisms that may or may not be present in a test sample. By detecting the presence or absence of microbial contamination in 18 h, it is superior in comparison to a 48-96 h incubation period by using either a standard or rapid detection method.

Broth Microdilution In Vitro Screening: An Easy and Fast Method to Detect New Antifungal Compounds.

PubMed

de-Souza-Silva, Calliandra Maria; Guilhelmelli, Fernanda; Zamith-Miranda, Daniel; de Oliveira, Marco Antônio; Nosanchuk, Joshua Daniel; Silva-Pereira, Ildinete; Albuquerque, Patrícia

2018-02-14

Fungal infections have become an important medical condition in the last decades, but the number of available antifungal drugs is limited. In this scenario, the search for new antifungal drugs is necessary. The protocol reported here details a method to screen peptides for their antifungal properties. It is based on the broth microdilution susceptibility test from the Clinical and Laboratory Standards Institute (CLSI) M27-A3 guidelines with modifications to suit the research of antimicrobial peptides as potential new antifungals. This protocol describes a functional assay to evaluate the activity of antifungal compounds and may be easily modified to suit any particular class of molecules under investigation. Since the assays are performed in 96-well plates using small volumes, a large-scale screening can be completed in a short amount of time, especially if carried out in an automation setting. This procedure illustrates how a standardized and adjustable clinical protocol can help the bench-work pursuit of new molecules to improve the therapy of fungal diseases.

[Standardization of terminology in laboratory medicine I].

PubMed

Yoon, Soo Young; Yoon, Jong Hyun; Min, Won Ki; Lim, Hwan Sub; Song, Junghan; Chae, Seok Lae; Lee, Chang Kyu; Kwon, Jung Ah; Lee, Kap No

2007-04-01

Standardization of medical terminology is essential for data transmission between health-care institutions or clinical laboratories and for maximizing the benefits of information technology. Purpose of our study was to standardize the medical terms used in the clinical laboratory, such as test names, units, terms used in result descriptions, etc. During the first year of the study, we developed a standard database of concept names for laboratory terms, which covered the terms used in government health care centers, their branch offices, and primary health care units. Laboratory terms were collected from the electronic data interchange (EDI) codes from National Health Insurance Corporation (NHIC), Logical Observation Identifier Names and Codes (LOINC) database, community health centers and their branch offices, and clinical laboratories of representative university medical centers. For standard expression, we referred to the English-Korean/ Korean-English medical dictionary of Korean Medical Association and the rules for foreign language translation. Programs for mapping between LOINC DB and EDI code and for translating English to Korean were developed. A Korean standard laboratory terminology database containing six axial concept names such as components, property, time aspect, system (specimen), scale type, and method type was established for 7,508 test observations. Short names and a mapping table for EDI codes and Unified Medical Language System (UMLS) were added. Synonym tables for concept names, words used in the database, and six axial terms were prepared to make it easier to find the standard terminology with common terms used in the field of laboratory medicine. Here we report for the first time a Korean standard laboratory terminology database for test names, result description terms, result units covering most laboratory tests in primary healthcare centers.

Standardization of Terminology in Laboratory Medicine II

PubMed Central

Lee, Kap No; Yoon, Jong-Hyun; Min, Won Ki; Lim, Hwan Sub; Song, Junghan; Chae, Seok Lae; Jang, Seongsoo; Ki, Chang-Seok; Bae, Sook Young; Kim, Jang Su; Kwon, Jung-Ah; Lee, Chang Kyu

2008-01-01

Standardization of medical terminology is essential in data transmission between health care institutes and in maximizing the benefits of information technology. The purpose of this study was to standardize medical terms for laboratory observations. During the second year of the study, a standard database of concept names for laboratory terms that covered those used in tertiary health care institutes and reference laboratories was developed. The laboratory terms in the Logical Observation Identifier Names and Codes (LOINC) database were adopted and matched with the electronic data interchange (EDI) codes in Korea. A public hearing and a workshop for clinical pathologists were held to collect the opinions of experts. The Korean standard laboratory terminology database containing six axial concept names, components, property, time aspect, system (specimen), scale type, and method type, was established for 29,340 test observations. Short names and mapping tables for EDI codes and UMLS were added. Synonym tables were prepared to help match concept names to common terms used in the fields. We herein described the Korean standard laboratory terminology database for test names, result description terms, and result units encompassing most of the laboratory tests in Korea. PMID:18756062

Evaluation of TECRA® broth, Bolton broth and direct plating for recovery of Campylobacter spp, from broiler carcass rinsates from several commercial processing plants

USDA-ARS?s Scientific Manuscript database

The purpose of this study was to compare a conventional culture broth method (Bolton enrichment broth containing lysed horse blood), a newly developed proprietary broth method (TECRA® Campylobacter enrichment) and direct plating for Campylobacter spp. recovery from chicken carcass rinses. Whole car...

42 CFR 493.1357 - Standard; laboratory director qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; laboratory director qualifications. 493... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1357 Standard...

42 CFR 493.1357 - Standard; laboratory director qualifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; laboratory director qualifications. 493... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1357 Standard...

Microbiological culture broth designed from food waste.

PubMed

Chalón, Miriam C; Terán, Victoria; Arena, Mario E; Oliszewki, Rubén; González, Silvia N

2013-01-30

The current trend of increasing air, water, and soil pollution is, in part, due to inadequate management of municipal solid waste (MSW). The relationship between public health and the collection, storage and improper disposal of solid waste has encouraged several studies and the results were attributed to the spread of over twenty human and animal diseases due to this interrelationship. The term "single cell protein" (SCP) refers to microbial biomass used as a dietary additive. It has high nutritional value because of its high content of vitamins, lipids, and proteins of biological quality (the presence of all essential amino acids) (Lal, 2005). The aim of this work was to design a culture media for microbiological assays and to produce SCP for animal feeding, using nutrients contained in organic waste. In order to compare the effectiveness of food waste (FW) and LAPTg media, different strains of Lactobacillus, Enterococcus, Staphylococcus, Shigella, Salmonella, Saccharomyces and Schizosaccharomyces were studied. In all cases, the growth obtained from FW and LAPTg culture media were not significantly different (p > 0.05). In addition, the growth of Saccharomyces cerevisiae was studied in order to produce SCP for animal feeding. Comparative experiments involving molasses broth, FW broth, and basal broth were carried out. The biomass yield calculated at 24 h from FW broth was 13% lower than from molasses broth. The FW broth provided a significantly lower biomass yield; however, it can be very useful in areas where molasses are not available. FW broth can be elaborated at low cost, in any populated region of the world because its ingredients are wastes generated by humans. It has great versatility, allowing the development of a wide variety of microorganisms, both Gram negative and Gram positive bacteria as well as yeasts. The production of safe protein additives, with high biological quality and low cost, is necessary due to the increasing global demand for food

In Vitro Comparison of Ertapenem, Meropenem, and Imipenem against Isolates of Rapidly Growing Mycobacteria and Nocardia by Use of Broth Microdilution and Etest

PubMed Central

Brown-Elliott, Barbara A.; Killingley, Jessica; Vasireddy, Sruthi; Bridge, Linda

2016-01-01

We compared the activities of the carbapenems ertapenem, meropenem, and imipenem against 180 isolates of rapidly growing mycobacteria (RGM) and 170 isolates of Nocardia using the Clinical and Laboratory Standards Institute (CLSI) guidelines. A subset of isolates was tested using the Etest. The rate of susceptibility to ertapenem and meropenem was limited and less than that to imipenem for the RGM. Analysis of major and minor discrepancies revealed that >90% of the isolates of Nocardia had higher MICs by the broth microdilution method than by Etest, in contrast to the lower broth microdilution MICs seen for >80% of the RGM. Imipenem remains the most active carbapenem against RGM, including Mycobacterium abscessus subsp. abscessus. For Nocardia, imipenem was significantly more active only against Nocardia farcinica. Although there may be utility in testing the activities of the newer carbapenems against Nocardia, their activities against the RGM should not be routinely tested. Testing by Etest is not recommended by the CLSI. PMID:27053677

Essential and toxic metals in animal bone broths

PubMed Central

Hsu, Der-jen; Lee, Chia-wei; Tsai, Wei-choung; Chien, Yeh-chung

2017-01-01

ABSTRACT Background: This investigation examines the extraction of metals from animal bones into broth, and assesses whether bone broths are good sources of essential metals and the risks associated with the consumption of toxic metals. Method:Three sets of controlled experiments were performed to study the factors (cooking time, acidity, bone type and animal species) that influence metal extractions. Three types of animal bone broth-based foods were also tested. Results: Reducing the broth pH from 8.38 to 5.32 significantly (p < 0.05) increased Ca and Mg extraction by factors of 17.4 and 15.3, respectively. A long cooking time, > 8 h, yielded significantly higher (p < 0.05) Ca and Mg extraction than shorter cooking times. The extraction characteristics of metals, particularly Ca, Mg, Cu and Al, from the leg and rib bones differed. The between-species variations in extraction were larger than those of within-species. Conclusions:The Ca and Mg levels in home-made or commercial broth/soup were found not to exceed low tenths of milligram per serving, or <5% of the daily recommended levels. The risks that are associated with the ingestion of heavy metals such as Pb and Cd in broth are minimal because the levels were in the ranges of a few μg per serving. PMID:28804437

The visual assessment of broth cultures for tissue bank samples.

PubMed

Varettas, Kerry

2017-09-01

The bioburden screening process of allograft musculoskeletal tissue samples received at the South Eastern Area Laboratory Services includes the routine use of solid agar and cooked meat (CM) broth media. CM has been routinely sub-cultured onto solid agar plates after aerobic incubation at 35 °C. This study will evaluate whether a visual assessment of CM can replace sub-culture by an in vitro inoculation and a prospective study. Eight challenge organisms were serially diluted and inoculated into CM. The average inoculum of 0.5-5.5 CFU produced visible turbidity of CM after 24-h incubation for 7 of the challenge organisms with one organism producing turbidity after 48-h incubation. The prospective study evaluated 222 CM of which 213 were visually clear and no-growth on sub-culture and 9 turbid CM which were culture positive. Broth cultures are an integral part of the bioburden screening process of allograft musculoskeletal tissue and swab samples and visual assessment of CM can replace sub-culture.

Limitations of Thioglycolate Broth as a Sterility Test Medium for Materials Exposed to Gaseous Ethylene Oxide1

PubMed Central

Doyle, John E.; Mehrhof, William H.; Ernst, Robert R.

1968-01-01

Although ethylene oxide is a reliable sterilizer, the process may be limited by diffusion. Thus, situations may exist where microorganisms are protected from the sterilizing gas. It is possible that the exterior of a substance may be sterilized, whereas the interior is not. We investigated three general types of materials in which this limitation of diffusion could occur: the bore of glass and plastic tubing, the center of cotton balls, and plastic adhesive film/paper backing interface. These materials were contaminated as close to their geometric center as possible with Bacillus subtilis var. niger spores occluded in crystals of sodium chloride. After exposure of the contaminated materials (except aluminum foil) to ethylene oxide, thioglycolate broth (a standard sterility-test medium) indicated sterility, whereas Trypticase Soy Broth indicated nonsterility. It is likewise possible that aerobic microorganisms, surviving in or on material after exposure to dry heat or steam sterilization processes, would not be recovered by thioglycollate broth. Entrapped aerobic organisms will probably not grow out in the low oxygen tension zone of an anaerobic medium such as thioglycollate broth. It is recommended than an aerobic medium such as Trypticase Soy Broth be used concurrently with thioglycolate broth for sterility testing. PMID:4973064

Multisite reproducibility of the broth microdilution method for susceptibility testing of Nocardia species.

PubMed

Conville, Patricia S; Brown-Elliott, Barbara A; Wallace, Richard J; Witebsky, Frank G; Koziol, Deloris; Hall, Geraldine S; Killian, Scott B; Knapp, Cindy C; Warshauer, David; Van, Tam; Wengenack, Nancy L; Deml, Sharon; Woods, Gail L

2012-04-01

Antimicrobial susceptibility testing (AST) of clinical isolates of Nocardia is recommended to detect resistance to commonly used antimicrobial agents; such testing is complicated by difficulties in inoculum preparation and test interpretation. In this study, six laboratories performed repetitive broth microdilution testing on single strains of Nocardia brasiliensis, Nocardia cyriacigeorgica, Nocardia farcinica, Nocardia nova, and Nocardia wallacei. For each isolate, a total of 30 microdilution panels from three different lots were tested at most sites. The goal of the study was to determine the inter- and intralaboratory reproducibility of susceptibility testing of this group of isolates. Acceptable agreement (>90% agreement at ±1 dilution of the MIC mode) was found for amikacin, ciprofloxacin, clarithromycin, and moxifloxacin. After eliminating MIC values from single laboratories whose results showed the greatest deviation from those of the remaining laboratories, acceptable agreement was also found for amoxicillin-clavulanic acid, linezolid, minocycline, and tobramycin. Results showed unsatisfactory reproducibility of broth microdilution testing of ceftriaxone with N. cyriacigeorgica and N. wallacei, tigecycline with N. brasiliensis and N. cyriacigeorgica, and sulfonamides with N. farcinica and N. wallacei. N. nova ATCC BAA-2227 is proposed as a quality control organism for AST of Nocardia sp., and the use of a disk diffusion test for sulfisoxazole is proposed as a check of the adequacy of the inoculum and to confirm sulfonamide MIC results.

Comparison of direct selective versus nonselective agar media plus LIM broth enrichment for determination of group B streptococcus colonization status in pregnant women.

PubMed

Elsayed, Sameer; Gregson, Daniel B; Church, Deirdre L

2003-06-01

Group B streptococcus (GBS) is the most common cause of early-onset neonatal sepsis in developed countries, and determination of the GBS colonization status in pregnant patients near term is essential for the provision of prophylactic measures to prevent early-onset disease. To determine if GBS recovery rates and/or result turnaround times for vaginal or combined vaginal/rectal swab specimens from pregnant patients near term are enhanced if swabs are inoculated initially onto selective versus nonselective agar media, in addition to the standard Centers for Disease Control and Prevention method. Prospective laboratory analysis. Urban health region/centralized diagnostic microbiology laboratory. Pregnant women presenting for routine obstetrical care and collection of vaginal or combined vaginal/rectal swab specimens for GBS testing at 35 to 37 weeks' gestation. Culture of specimens directly onto selective (5% sheep blood with colistin and nalidixic acid) or nonselective (5% sheep blood) agar media, in addition to LIM broth enrichment and terminal subculture. Group B streptococcus recovery rate and culture result turnaround time. A total of 639 specimens were tested, with 128 (20%) positive for GBS. Sixty-three isolates were recovered on direct agar media at 24 hours, of which 16 (12.5%) were isolated on selective plates only. An additional 38 isolates were recovered at 48 hours from direct plates. Twenty-seven (21.1%) isolates that failed to grow on direct plates were recovered from the LIM broth subculture only. Three (2.3%) isolates not recovered from LIM broths were detected at 48 hours on the direct selective (2 isolates) and nonselective (1 isolate) agar plates. A 24-hour result turnaround time was achieved for 63 (49.2%) and 47 (36.7%) of the 128 culture-positive specimens for direct selective and nonselective plates, respectively (chi2 = 76.63, P <.001). Use of direct selective agar media, in addition to LIM broth enrichment, for the determination of the GBS

The OSHA hazardous chemical occupational exposure standard for laboratories.

PubMed

Armbruster, D A

1991-01-01

OSHA's chemical occupational exposure standard for laboratories is an outgrowth of the previously issued Hazard Communication Standard. The standard relieves laboratories from complying with general industry standards but does require compliance with specific laboratory guidelines. The heart of the standard is the creation of a Chemical Hygiene Plan (CHP). The CHP addresses major issues such as safety equipment and procedures, work practices, training, the designation of a chemical hygiene officer, and the provision of medical consultation and examination for affected employees. This new standard, in full effect as of January 31, 1991, presents yet another regulatory challenge to laboratory managers but also ensures a safer environment for laboratory workers.

Comparison of direct-plating and broth-enrichment culture methods for detection of potential bacterial pathogens in respiratory secretions.

PubMed

Kaur, Ravinder; Wischmeyer, Jareth; Morris, Matthew; Pichichero, Michael E

2017-11-01

We compared the recovery of potential respiratory bacterial pathogens and normal flora from nasopharyngeal specimens collected from children during health and at the onset of acute otitis media (AOM) by selective direct-plating and overnight broth-enrichment. Overall, 3442 nasal wash (NW) samples collected from young children were analysed from a 10-year prospective study. NWs were cultured by (1) direct-plating to TSAII/5 % sheep blood agar and chocolate agar plates and (2) overnight broth-enrichment in BacT/ALERT SA-broth followed by plating. Standard microbiology techniques were applied to identify three dominant respiratory bacterial pathogens: Streptococcus pneumoniae (Spn), Haemophilus influenzae (Hflu) and Moraxella catarrhalis (Mcat) as well as two common nasal flora, Staphylococcus aureus (SA) and alpha-haemolytic Streptococci (AHS).Results/Key findings. Direct-plating of NW resulted in isolation of Spn from 37.8 %, Hflu from 13.6 % and Mcat from 33.2 % of samples. In comparison, overnight broth-enrichment isolated fewer Spn (30.1 %), Hflu (6.2 %) and Mcat (16.2 %) (P<0.001-0.0001). Broth-enrichment resulted in significant increased isolation of SA (6.0 %) and AHS (30.1 %) (P<0.0001). Competition between bacterial species in broth when both species were detected by direct-plating was assessed, and it was found that SA and AHS out-competed other species during broth-enrichment when samples were collected from healthy children but not during AOM. In middle ear fluids (MEF) at the onset of AOM, broth-enrichment resulted in higher recovery of Spn (+10.4 %, P<0.001), Hflu (+4.4 %, P=0.39) and Mcat (+13.5 %, <0.001). Broth-enrichment significantly reduces the accurate detection of bacterial respiratory pathogens and increases identification of SA and AHS in NW. Broth-enrichment improves detection of bacterial respiratory pathogens in MEF samples.

Certification standards transfer: from committee to laboratory.

PubMed

Lehmann, H P

1998-12-01

The ISO 9000 Standards series were developed to provide the international manufacturing industry with a framework to ensure purchased products meet quality criteria. Section 4 of ISO 9001, Quality System Model for Quality Assurance in Design, Development, Production, Installation and Servicing, contains 20 aspects of a quality system that must be addressed by an organization in order to receive ISO 9001 certification. This concept is extended to the clinical laboratory, where a quality system program establishes for the customer (patient/clinician) that the purchased product (requested information on a submitted specimen-test result) meets established quality norms. In order to satisfy the customer, the providing organization must have policies and procedures in place that ensure a quality product, and be certified. To become certified the organization must, through an inspection process, demonstrate to an independent accrediting agency that it meets defined standards. In the United States, the government through the Clinical Laboratory Improvement Amendment (CLIA) 1988 established quality standards for the clinical laboratory. The College of American Pathologists (CAP), through its Laboratory Accreditation Program (LAP), serves as an independent agency that certifies that laboratories meet standards. To demonstrate the applicability of an established clinical laboratory accreditation program to ISO 9001 certification, the standards and checklists of CLIA 1988 and the CAP LAP will be examined to determine their conformance to ISO 9001, Section 4.

OSHA Laboratory Standard: Driving Force for Laboratory Safety!

ERIC Educational Resources Information Center

Roy, Kenneth R.

2000-01-01

Discusses the Occupational Safety and Health Administration's (OSHA's) Laboratory Safety Standards as the major driving force in establishing and maintaining a safe working environment for teachers and students. (Author)

42 CFR 493.1443 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Laboratory director qualifications. 493.1443 Section 493.1443 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1443 Standard; Laboratory director...

42 CFR 493.1443 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director qualifications. 493.1443 Section 493.1443 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1443 Standard; Laboratory director...

42 CFR 493.1445 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director responsibilities. 493.1445 Section 493.1445 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1445 Standard; Laboratory director...

42 CFR 493.1407 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director responsibilities. 493.1407 Section 493.1407 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing Moderate Complexity Testing § 493.1407 Standard; Laboratory director...

42 CFR 493.1359 - Standard; PPM laboratory director responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; PPM laboratory director responsibilities... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1359 Standard...

[Accreditation of clinical laboratories based on ISO standards].

PubMed

Kawai, Tadashi

2004-11-01

International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

Clinical pathology accreditation: standards for the medical laboratory

PubMed Central

Burnett, D; Blair, C; Haeney, M R; Jeffcoate, S L; Scott, K W M; Williams, D L

2002-01-01

This article describes a new set of revised standards for the medical laboratory, which have been produced by Clinical Pathology Accreditation (UK) Ltd (CPA). The original standards have been in use since 1992 and it was recognised that extensive revision was required. A standards revision group was established by CPA and this group used several international standards as source references, so that the resulting new standards are compatible with the most recent international reference sources. The aim is to make the assessment of medical laboratories as objective as possible in the future. CPA plans to introduce these standards in the UK in 2003 following extensive consultation with professional bodies, piloting in selected laboratories, and training of assessors. PMID:12354795

[Recent trends in the standardization of laboratory automation].

PubMed

Tao, R; Yamashita, K

2000-10-01

Laboratory automation systems have been introduced to many clinical laboratories since early 1990s. Meanwhile, it was found that the difference in the specimen tube dimensions, specimen identification formats, specimen carrier transportation equipment architecture, electromechanical interfaces between the analyzers and the automation systems was preventing the systems from being introduced to a wider extent. To standardize the different interfaces and reduce the cost necessary for the laboratory automation, NCCLS and JCCLS started establishing standards for the laboratory automation in 1996 and 1997 respectively. NCCLS has published five proposed standards which that are expected to be approved by the end of 2000.

In vitro susceptibility of filamentous fungi to itraconazole, voriconazole and posaconazole by Clinical and Laboratory Standards Institute reference method and E-test.

PubMed

Kondori, N; Svensson, E; Mattsby-Baltzer, I

2011-09-01

The use of anti-fungal agents has increased dramatically in recent years and new drugs have been developed. Several methods are available for determinations of their specific biological activities, i.e. the standard method for minimum inhibitory concentration-determination is described in M-38 [Clinical and Laboratory Standards Institute document M-38 (CLSI M-38)]. However, alternative methods, such as the E-test, are currently available in Mycology laboratories. The susceptibilities of clinical isolates of Aspergillus spp. (n = 29), Fusarium spp. (n = 5), zygomycetes (n = 21) and Schizophyllum (n = 1) were determined for itraconazole, voriconazole and posaconazole, using the CLSI M-38-A broth dilution method and also by the E-test. A good overall agreement (83.7%) between the two methods for all drugs and organisms was observed. Analyses of voriconazole showed a better agreement (93%) between the methods than posaconazole and itraconazole (85% and 74% respectively). Aspergillus spp. were the most susceptible fungi to the anti-fungal agents tested in this study. Posaconazole was the most active drug against filamentous fungi in vitro, followed by itraconazole and voriconazole. The latter (voriconazole) demonstrated no significant in vitro activity against zygomycetes. © 2010 Blackwell Verlag GmbH.

In Vitro Comparison of Ertapenem, Meropenem, and Imipenem against Isolates of Rapidly Growing Mycobacteria and Nocardia by Use of Broth Microdilution and Etest.

PubMed

Brown-Elliott, Barbara A; Killingley, Jessica; Vasireddy, Sruthi; Bridge, Linda; Wallace, Richard J

2016-06-01

We compared the activities of the carbapenems ertapenem, meropenem, and imipenem against 180 isolates of rapidly growing mycobacteria (RGM) and 170 isolates of Nocardia using the Clinical and Laboratory Standards Institute (CLSI) guidelines. A subset of isolates was tested using the Etest. The rate of susceptibility to ertapenem and meropenem was limited and less than that to imipenem for the RGM. Analysis of major and minor discrepancies revealed that >90% of the isolates of Nocardia had higher MICs by the broth microdilution method than by Etest, in contrast to the lower broth microdilution MICs seen for >80% of the RGM. Imipenem remains the most active carbapenem against RGM, including Mycobacterium abscessus subsp. abscessus For Nocardia, imipenem was significantly more active only against Nocardia farcinica Although there may be utility in testing the activities of the newer carbapenems against Nocardia, their activities against the RGM should not be routinely tested. Testing by Etest is not recommended by the CLSI. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Reverse Osmosis Processing of Organic Model Compounds and Fermentation Broths

DTIC Science & Technology

2006-04-01

AFRL-ML-TY-TP-2007-4545 POSTPRINT REVERSE OSMOSIS PROCESSING OF ORGANIC MODEL COMPOUNDS AND FERMENTATION BROTHS Robert Diltz...TELEPHONE NUMBER (Include area code) Bioresource Technology 98 (2007) 686–695Reverse osmosis processing of organic model compounds and fermentation broths...December 2005; accepted 31 January 2006 Available online 4 April 2006Abstract Post-treatment of an anaerobic fermentation broth was evaluated using a 150

Standardization of Laboratory Methods for the PERCH Study

PubMed Central

Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

2017-01-01

Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

Laboratory Diagnosis and Susceptibility Testing for Mycobacterium tuberculosis.

PubMed

Procop, Gary W

2016-12-01

The laboratory, which utilizes some of the most sophisticated and rapidly changing technologies, plays a critical role in the diagnosis of tuberculosis. Some of these tools are being employed in resource-challenged countries for the rapid detection and characterization of Mycobacterium tuberculosis. Foremost, the laboratory defines appropriate specimen criteria for optimal test performance. The direct detection of mycobacteria in the clinical specimen, predominantly done by acid-fast staining, may eventually be replaced by rapid-cycle PCR. The widespread use of the Xpert MTB/RIF (Cepheid) assay, which detects both M. tuberculosis and key genetic determinants of rifampin resistance, is important for the early detection of multidrug-resistant strains. Culture, using both broth and solid media, remains the standard for establishing the laboratory-based diagnosis of tuberculosis. Cultured isolates are identified far less commonly by traditional biochemical profiling and more commonly by molecular methods, such as DNA probes and broad-range PCR with DNA sequencing. Non-nucleic acid-based methods of identification, such as high-performance liquid chromatography and, more recently, matrix-assisted laser desorption/ionization-time of flight mass spectrometry, may also be used for identification. Cultured isolates of M. tuberculosis should be submitted for susceptibility testing according to standard guidelines. The use of broth-based susceptibility testing is recommended to significantly decrease the time to result. Cultured isolates may also be submitted for strain typing for epidemiologic purposes. The use of massive parallel sequencing, also known as next-generation sequencing, promises to continue to this molecular revolution in mycobacteriology, as whole-genome sequencing provides identification, susceptibility, and typing information simultaneously.

Enhanced recovery of Salmonella from apple cider and apple juice with universal preenrichment broth.

PubMed

Hammack, Thomas S; Johnson, Mildred L; Jacobson, Andrew P; Andrews, Wallace H

2002-01-01

A comparison was made of the relative efficiencies of Universal Preenrichment (UP) broth and lactose broth for the recovery of a variety of Salmonella serovars from pasteurized and unpasteurized apple cider and pasteurized apple juice. Bulk portions of juice were contaminated with single Salmonella serovars at high and low levels of 0.4 and 0.04 CFU/mL, respectively. The juice was aged for a minimum of 5 days at 2-5 degrees C. On the day analysis was initiated, each of 20 test portions (25 mL) of the contaminated juice was preenriched in UP broth and in lactose broth. The Bacteriological Analytical Manual Salmonella culture method was followed thereafter. For pasteurized apple cider, UP broth recovered significantly (p < 0.05) more Salmonella-positive test portions than did lactose broth (112 and 75, respectively). For unpasteurized apple cider, UP broth recovered significantly more Salmonella-positive test portions than did lactose broth (326 and 221, respectively). For pasteurized apple juice, UP broth recovered more Salmonella-positive test portions than did lactose broth (93 and 81, respectively). However, this difference was not statistically significant. These results indicate that UP broth should replace lactose broth for the analysis of pasteurized and unpasteurized apple cider and pasteurized apple juice.

Collaborative investigation of broth microdilution and semisolid agar dilution for in vitro susceptibility testing of Candida albicans.

PubMed Central

Shawar, R; Paetznick, V; Witte, Z; Ensign, L G; Anaissie, E; LaRocco, M

1992-01-01

A study was performed in two laboratories to evaluate the effect of growth medium and test methodology on inter- and intralaboratory variations in the MICs of amphotericin B (AMB), flucytosine (5FC), fluconazole (FLU), itraconazole (ITRA), and the triazole Sch 39304 (SCH) against 14 isolates of Candida albicans. Testing was performed by broth microdilution and semisolid agar dilution with the following media, buffered to pH 7.0 with morpholinepropanesulfonic acid (MOPS): buffered yeast nitrogen base (BYNB), Eagle's minimal essential medium (EMEM), RPMI 1640 medium (RPMI), and synthetic amino acid medium for fungi (SAAMF). Inocula were standardized spectrophotometrically, and endpoints were defined by the complete absence of growth for AMB and by no more than 25% of the growth in the drug-free control for all other agents. Comparative analyses of median MICs, as determined by each test method, were made for all drug-medium combinations. Both methods yielded similar (+/- 1 twofold dilution) median MICs for AMB in EMEM and RPMI, 5FC in all media, and FLU in EMEM, RPMI, and SAAMF. In contrast, substantial between-method variations in median MICs were seen for AMB in BYNB and SAAMF, FLU In BYNB, and ITRA and SCH in all media. Interlaboratory concordance of median MICs was good for AMB, 5FC, and FLU but poor for ITRA and SCH in all media. Endpoint determinations were analyzed by use of kappa statistical analyses for evaluating the strength of observer agreement. Moderate to almost perfect interlaboratory agreement occurred with AMB and 5FC in all media and with FLU in EMEM, RPMI, and SAAMF, irrespective of the test method. Slight to almost perfect interlaboratory agreement occurred with ITRA and SCH in EMEM, RPMI, and SAAMF when tested by semisolid agar dilution but not broth microdilution. Kappa values assessing intralaboratory agreement between methods were high for 5FC in all media, for AMB in BYNB, ENEM, and RPMI, and for FLU in EMEM, RPMI, and SAAMF. One laboratory

Collaborative investigation of broth microdilution and semisolid agar dilution for in vitro susceptibility testing of Candida albicans.

PubMed

Shawar, R; Paetznick, V; Witte, Z; Ensign, L G; Anaissie, E; LaRocco, M

1992-08-01

A study was performed in two laboratories to evaluate the effect of growth medium and test methodology on inter- and intralaboratory variations in the MICs of amphotericin B (AMB), flucytosine (5FC), fluconazole (FLU), itraconazole (ITRA), and the triazole Sch 39304 (SCH) against 14 isolates of Candida albicans. Testing was performed by broth microdilution and semisolid agar dilution with the following media, buffered to pH 7.0 with morpholinepropanesulfonic acid (MOPS): buffered yeast nitrogen base (BYNB), Eagle's minimal essential medium (EMEM), RPMI 1640 medium (RPMI), and synthetic amino acid medium for fungi (SAAMF). Inocula were standardized spectrophotometrically, and endpoints were defined by the complete absence of growth for AMB and by no more than 25% of the growth in the drug-free control for all other agents. Comparative analyses of median MICs, as determined by each test method, were made for all drug-medium combinations. Both methods yielded similar (+/- 1 twofold dilution) median MICs for AMB in EMEM and RPMI, 5FC in all media, and FLU in EMEM, RPMI, and SAAMF. In contrast, substantial between-method variations in median MICs were seen for AMB in BYNB and SAAMF, FLU In BYNB, and ITRA and SCH in all media. Interlaboratory concordance of median MICs was good for AMB, 5FC, and FLU but poor for ITRA and SCH in all media. Endpoint determinations were analyzed by use of kappa statistical analyses for evaluating the strength of observer agreement. Moderate to almost perfect interlaboratory agreement occurred with AMB and 5FC in all media and with FLU in EMEM, RPMI, and SAAMF, irrespective of the test method. Slight to almost perfect interlaboratory agreement occurred with ITRA and SCH in EMEM, RPMI, and SAAMF when tested by semisolid agar dilution but not broth microdilution. Kappa values assessing intralaboratory agreement between methods were high for 5FC in all media, for AMB in BYNB, ENEM, and RPMI, and for FLU in EMEM, RPMI, and SAAMF. One laboratory

42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: General laboratory systems quality... for Nonwaived Testing General Laboratory Systems § 493.1239 Standard: General laboratory systems... laboratory systems requirements specified at §§ 493.1231 through 493.1236. (b) The general laboratory systems...

Development of Similar Broth Microdilution Methods to Determine the Antimicrobial Susceptibility of Flavobacterium columnare and F. psychrophilum.

PubMed

Gieseker, Charles M; Crosby, Tina C; Mayer, Tamara D; Bodeis, Sonya M; Stine, Cynthia B

2016-03-01

Flavobacterium columnare and F. psychrophilum are major fish pathogens that cause diseases that may require antimicrobial therapy. Choice of appropriate treatment is dependent upon determining the antimicrobial susceptibility of isolates. Therefore we optimized methods for broth microdilution testing of F. columnare and F. psychrophilum to facilitate standardizing an antimicrobial susceptibility test. We developed adaptations to make reproducible broth inoculums and confirmed the proper incubation time and media composition. We tested the stability of potential quality-control bacteria and compared test results between different operators. Log phase occurred at 48 h for F. columnare and 72-96 h for F. psychrophilum, confirming the test should be incubated at 28°C for approximately 48 h and at 18°C for approximately 96 h, respectively. The most consistent susceptibility results were achieved with plain, 4-g/L, dilute Mueller-Hinton broth supplemented with dilute calcium and magnesium. Supplementing the broth with horse serum did not improve growth. The quality-control strains, Escherichia coli ATCC 25922 and Aeromonas salmonicida subsp. salmonicida ATCC 33658, yielded stable minimal inhibitory concentrations (MIC) against all seven antimicrobials tested after 30 passes at 28°C and 15 passes at 18°C. In comparison tests, most MICs of the isolates agreed 100% within one drug dilution for ampicillin, florfenicol, and oxytetracycline. The agreement was lower with the ormetoprim-sulfdimethoxine combination, but there was at least 75% agreement for all but one isolate. These experiments have provided methods to help standardize antimicrobial susceptibility testing of these nutritionally fastidious aquatic bacteria. Received June 24, 2015; accepted October 2, 2015.

Rheology and hydrodynamic properties of Tolypocladium inflatum fermentation broth and its simulation.

PubMed

Benchapattarapong, N; Anderson, W A; Bai, F; Moo-Young, M

2005-07-01

A physico-chemical, two phase simulated pseudoplastic fermentation (SPF) broth was investigated in which Solka Floc cellulose fibre was used to simulate the filamentous biomass, and a mixture of 0.1% (w/v) carboxymethyl cellulose (CMC) and 0.15 M aqueous sodium chloride was used to simulate the liquid fraction of the fermentation broth. An investigation of the rheological behaviour and hydrodynamic properties of the SPF broth was carried out, and compared to both a fungal Tolypocladium inflatum fermentation broth and a CMC solution in a 50 L stirred tank bioreactor equipped with conventional Rushton turbines. The experimental data confirmed the ability of the two phase SPF broth to mimic both the T. inflatum broth bulk rheology as well as the mixing and mass transfer behaviour. In contrast, using a homogeneous CMC solution with a similar bulk rheology to simulate the fermentation resulted in a significant underestimation of the mass transfer and mixing times. The presence of the solid phase and its microstructure in the SPF broth appear to play a significant role in gas holdup and bubble size, thus leading to the different behaviours. The SPF broth seems to be a more accurate simulation fluid that can be used to predict the bioreactor mixing and mass transfer performance in filamentous fermentations, in comparison with CMC solutions used in some previous studies.

Performance characteristics of broth-only cultures after revision total joint arthroplasty.

PubMed

Smith, Eric B; Cai, Jenny; Wynne, Rachael; Maltenfort, Mitchell; Good, Robert P

2014-11-01

Surgeons frequently obtain intraoperative cultures at the time of revision total joint arthroplasty. The use of broth or liquid medium before applying the sample to the agar medium may be associated with contamination and false-positive cultures; however, the degree to which this is the case is not known. We (1) calculated the performance characteristics of broth-only cultures (sensitivity, specificity, positive predictive value, and negative predictive value) and (2) characterized the organisms identified in broth to determine whether a specific organism showed increased proclivity for true-positive periprosthetic joint infection (PJI). A single-institution retrospective chart review was performed on 257 revision total joint arthroplasties from 2009 through 2010. One hundred ninety (74%) had cultures for review. All culture results, as well as treatment, if any, were documented and patients were followed for a minimum of 1 year for evidence of PJI. Cultures were measured as either positive from the broth only or broth negative. The true diagnosis of infection was determined by the Musculoskeletal Infection Society criteria during the preoperative workup or postoperatively at 1 year for purposes of calculating the performance characteristics of the broth-only culture. The sensitivity, specificity, positive predictive value, and negative predictive value were 19%, 88%, 13%, and 92%, respectively. The most common organism identified was coagulase-negative Staphylococcus (16 of 24 cases, 67%). Coagulase-negative Staphylococcus was present in all three true-positive cases; however, it was also found in 13 of the false-positive cases. The broth-only positive cultures showed poor sensitivity and positive predictive value but good specificity and negative predictive value. The good specificity indicates that it can help to rule in the presence of PJI; however, the poor sensitivity makes broth-only culture an unreliable screening test. We recommend that broth

Validation of EUCAST zone diameter breakpoints against reference broth microdilution.

PubMed

Bengtsson, S; Bjelkenbrant, C; Kahlmeter, G

2014-06-01

The European Committee on Antimicrobial Susceptibility Testing (EUCAST) began harmonizing clinical breakpoints in Europe 2002. In 2009, work to develop a disc diffusion method began and the first disc diffusion breakpoints calibrated to EUCAST clinical MIC breakpoints were published in December 2009. In this study we validated EUCAST clinical zone diameter breakpoints against the International Standard Organization (ISO) reference broth microdilution. A collection of 544 isolates (238 Gram-negative and 306 Gram-positive) were tested against a panel of antimicrobial agents. Antimicrobial susceptibility testing was performed with broth microdilution as described by ISO and disc diffusion in accordance with EUCAST methodology. Inhibition zone diameters and MIC values were interpreted and categorized (S, I and R) according to EUCAST clinical breakpoint table version 2.0. Categorical agreement (CA) as well as minor (mD), major (MD) and very major (VMD) discrepancies were determined. There was in general good correlation between susceptibility test results obtained with disc diffusion and broth microdilution. Overall CA was 97.3% for all combinations of organisms and antimicrobial agents (n = 5231) and the overall discrepancy rates were 110 (2.1%) mD, 24 (0.5%) MD and 7 (0.1%) VMD. The overall CA for Gram-positive and Gram-negative organisms were 98.7% (2346 tests) and 96.2% (2942 tests), respectively. Seven VMD were observed, five for Gram-positive organisms (coagulase negative staphylococci (n = 2) and Staphylococcus aureus (n = 3)) and two for Gram-negative organisms (Pseudomonas aeruginosa). Minor discrepancies were mainly observed in Gram-negatives and were related to different antimicrobial agents and species. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

In vitro susceptibility of bovine mastitis pathogens to a combination of penicillin and framycetin: development of interpretive criteria for testing by broth microdilution and disk diffusion.

PubMed

Pillar, C M; Stoneburner, A; Shinabarger, D L; Abbeloos, E; Goby, L; Bradley, Andrew J

2014-10-01

Dry cow therapy is an important part of mastitis control. This therapy typically consists of an antibiotic or antibiotics administered at a single dose by intramammary infusion at dry off to treat or prevent infection by prevalent mastitis pathogens. A combination dry cow therapy consisting of the active components penicillin and framycetin is currently used in several countries. Despite its use, standardized methods for the susceptibility testing of this combination against mastitis pathogens have not been established. In this study, which used Clinical and Laboratory Standards Institute methodology, preliminary interpretive criteria for the broth microdilution minimum inhibitory concentration (MIC) testing of mastitis pathogens to penicillin combined with framycetin (2:1 wt/wt) were established based on the amount of drug achieved and maintained postadministration in the udder. Based on resulting MIC distributions of recent veterinary field isolates and a subset of isolates preselected for resistance to β-lactams or aminoglycosides and concentrations achieved postadministration, criteria for broth microdilution testing of the combination (susceptible, intermediate, resistant in micrograms per milliliter) were set as follows: Escherichia coli ≤8/4, 16/8, ≥32/16; Staphylococcus spp. ≤2/1, 4/2-8/4, >16/8; Streptococcus uberis and Streptococcus dysgalactiae <0.25/0.12, 0.5/0.25-2/1, >4/2. A disk diffusion test using disks containing 100 μg of framycetin and 10 IU of penicillin was also developed, and preliminary interpretive criteria (susceptible, intermediate, resistant in millimeters) were set based on correlation to broth MIC values and the minimization of interpretive errors between isolates tested concurrently by broth microdilution and disk diffusion as follows: E. coli ≥18, 16-17, ≤15; Staphylococcus spp. ≥21, 18-20, ≤17; Strep. uberis and Strep. dysgalactiae ≥21, 19-20, ≤18. In addition, ranges for the quality control of the testing of

Polymyxin B Etest® compared with gold-standard broth microdilution in carbapenem-resistant Enterobacteriaceae exhibiting a wide range of polymyxin B MICs.

PubMed

Kulengowski, B; Ribes, J A; Burgess, D S

2018-04-16

Polymyxins have been revitalized to combat carbapenem-resistant Enterobacteriaceae (CRE). However, evaluating the activity of these agents by traditional broth dilution methods is not practical for busy clinical laboratories. We compared polymyxin B activity using two quantitative susceptibility testing methods, Etest ® and broth microdilution (BMD), against CRE isolates from patients at an academic medical centre. Polymyxin B activity against 70 CRE clinical isolates was determined by Etest ® according to the manufacturer and by BMD according to CLSI guidelines. Pseudomonas aeruginosa ATCC ® 27853 and Escherichia coli NCTC 13846 served as quality control strains. The EUCAST colistin susceptibility breakpoint of Enterobacteriaceae (≤2 mg/L) was used. Essential agreement was isolates with an MIC within 1 log 2 dilution over total isolates. Categorical agreement was number of isolates in the same susceptibility category (susceptible or resistant) over total isolates. Major and very major error rates were calculated using number of susceptible and number of resistant isolates, respectively, as the denominator. McNemar's test was used for determining a difference in susceptibility between methods. The CRE isolates were primarily Klebsiella spp. (49%) and Enterobacter spp. (36%). Polymyxin B susceptibility was significantly higher by Etest ® compared with BMD (97% versus 77%; p 0.0001). Categorical agreement was 80%, but essential agreement was low (10%). False non-susceptibility was never observed by Etest ® (BMD reference), but the very major errors were high (88%). Etest ® reporting of false susceptibility may result in inappropriate antibiotic use and treatment failure clinically. We do not recommend using Etest ® for polymyxin B susceptibility testing for routine patient care. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

VIEW OF THE INTERIOR OF BUILDING 125, THE STANDARDS LABORATORY. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

VIEW OF THE INTERIOR OF BUILDING 125, THE STANDARDS LABORATORY. THE PRIMARY FUNCTION OF THE STANDARDS LABORATORY WAS TO ENSURE AND IMPLEMENT A SYSTEM OF QUALITY CONTROL FOR INCOMING MATERIALS USED IN MANUFACTURING PROCESSES. SEVERAL ENGINEERING CONTROLS WERE USED TO ASSURE ACCURACY OF THE CALIBRATION PROCESSES INCLUDING: FLEX-FREE GRANITE TABLES, AIR LOCKED DOORS, TEMPERATURE CONTROLS, AND A SUPER-CLEAN ENVIRONMENT - Rocky Flats Plant, Standards Laboratory, Immediately north of 215A water tower & adjacent to Third Street, Golden, Jefferson County, CO

Review and comparison of quality standards, guidelines and regulations for laboratories.

PubMed

Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

2012-01-01

The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

Salmonella testing of pooled pre-enrichment broth cultures for screening multiple food samples.

PubMed

Price, W R; Olsen, R A; Hunter, J E

1972-04-01

A method has been described for testing multiple food samples for Salmonella without loss in sensitivity. The method pools multiple pre-enrichment broth cultures into single enrichment broths. The subsequent stages of the Salmonella analysis are not altered. The method was found applicable to several dry food materials including nonfat dry milk, dried egg albumin, cocoa, cottonseed flour, wheat flour, and shredded coconut. As many as 25 pre-enrichment broth cultures were pooled without apparent loss in the sensitivity of Salmonella detection as compared to individual sample analysis. The procedure offers a simple, yet effective, way to increase sample capacity in the Salmonella testing of foods, particularly where a large proportion of samples ordinarily is negative. It also permits small portions of pre-enrichment broth cultures to be retained for subsequent individual analysis if positive tests are found. Salmonella testing of pooled pre-enrichment broths provides increased consumer protection for a given amount of analytical effort as compared to individual sample analysis.

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2010 CFR

2010-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope of the laboratory environmental management standard? The Laboratory Environmental Management Standard... environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of general laboratory systems quality assessment reviews with appropriate staff. (c) The laboratory must document all general laboratory systems quality assessment activities. [68 FR 3703, Jan. 24, 2003... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: General laboratory systems quality...

Production of Viscous Dextran-Containing Whey-Sucrose Broths by Leuconostoc mesenteroides ATCC 14935.

PubMed

Schwartz, R D; Bodie, E A

1984-09-01

Viscous broths were produced by growing Leuconostoc mesenteroides on a medium containing whey supplemented with sucrose. When combined with similarly produced xanthan-containing broths, a synergistic increase in viscosity was observed.

Removing Bacillus subtilis from fermentation broth using alumina nanoparticles.

PubMed

Mu, Dashuai; Mu, Xin; Xu, Zhenxing; Du, Zongjun; Chen, Guanjun

2015-12-01

In this study, an efficient separation technology using Al2O3 nanoparticles (NPs) was developed for removing Bacillus subtilis from fermentation broth. The dosage of alumina nanoparticles used for separating B. subtilis increased during the culture process and remained stable in the stationary phase of the culture process. The pH of the culture-broth was also investigated for its effects on flocculation efficiency, and showed an acidic pH could enhance the flocculation efficiency. The attachment mechanisms of Al2O3 NPs to the B. subtilis surface were investigated, and the zeta potential analysis showed that Al2O3 NPs could attach to B. subtilis via electrostatic attachment. Finally, the metabolite content and the antibacterial effect of the fermentation supernatants were detected and did not significantly differ between alumina nanoparticle separation and centrifugation separation. Together, these results indicate a great potential for a highly efficient and economical method for removing B. subtilis from fermentation broth using alumina nanoparticles. Copyright © 2015 Elsevier Ltd. All rights reserved.

Production of Viscous Dextran-Containing Whey-Sucrose Broths by Leuconostoc mesenteroides ATCC 14935

PubMed Central

Schwartz, Robert D.; Bodie, Elizabeth A.

1984-01-01

Viscous broths were produced by growing Leuconostoc mesenteroides on a medium containing whey supplemented with sucrose. When combined with similarly produced xanthan-containing broths, a synergistic increase in viscosity was observed. PMID:16346633

[Kinetic simulation of enhanced biological phosphorus removal with fermentation broth as carbon source].

PubMed

Zhang, Chao; Chen, Yin-Guang

2013-07-01

As a high-quality carbon source, fermentation broth could promote the phosphorus removal efficiency in enhanced biological phosphorus removal (EBPR). The transformation of substrates in EBPR fed with fermentation broth was well simulated using the modified activated sludge model No. 2 (ASM2) based on the carbon source metabolism. When fermentation broth was used as the sole carbon source, it was found that heterotrophic bacteria acted as a promoter rather than a competitor to the phosphorus accumulating organisms (PAO). When fermentation broth was used as a supplementary carbon source of real municipal wastewater, the wastewater composition was optimized for PAO growth; and the PAO concentration, which was increased by 3.3 times compared to that in EBPR fed with solely real municipal wastewater, accounting for about 40% of the total biomass in the reactor.

Effect of beef broth protein on the thermal inactivation of staphylococcal enterotoxin B1.

PubMed Central

Lee, I C; Stevenson, K E; Harmon, L G

1977-01-01

Enterotoxin B produced by Staphylococus aureus 243 in brain heart infusion broth was concentrated by dialysis against 40% polyethylene glycol (20 M), partially purified on a Sephadex G-100 column and heated at 110 degrees C in thermal death time cans. Various heating menstrua included 0.04 M Veronal buffer (pH 7.4), beef broth, and fractions of beef broth obtained by ultrafiltration or precipitation with ammonium sulfate. The toxin was assayed serologically using the microslide gel double-diffusion method. The time requiring for 90% inactivation at 110 degrees C (D110 value) obtained in buffer and in beef broth was 18 and 60 min, respectively. When the concentration of beef broth was increased fivefold, the D110 increased to 78 min. The apparent protective effect or protein was further investigated using beef broth protein obtained by precipitation with (NH4)2SO4. The D110 values were 51 and 70 min when the protein concentration in the heating menstruum was 3.8 and 7.7 mg/ml, respectively. However, when the beef broth protein was dialyzed against buffer before use as a heating menstrum, the D110 was only 39 or 41 min at comparable protein concentrations. Results indicated a dialyzable factor, whose protective effect was partially destroyed by trypsin and chymotrypsin but did not by disodium ethylenediaminetetraacetate, was involved in the protection of enterotoxin B during heating. PMID:403860

Transfer Standard Uncertainty Can Cause Inconclusive Inter-Laboratory Comparisons

PubMed Central

Wright, John; Toman, Blaza; Mickan, Bodo; Wübbeler, Gerd; Bodnar, Olha; Elster, Clemens

2016-01-01

Inter-laboratory comparisons use the best available transfer standards to check the participants’ uncertainty analyses, identify underestimated uncertainty claims or unknown measurement biases, and improve the global measurement system. For some measurands, instability of the transfer standard can lead to an inconclusive comparison result. If the transfer standard uncertainty is large relative to a participating laboratory’s uncertainty, the commonly used standardized degree of equivalence ≤ 1 criterion does not always correctly assess whether a participant is working within their uncertainty claims. We show comparison results that demonstrate this issue and propose several criteria for assessing a comparison result as passing, failing, or inconclusive. We investigate the behavior of the standardized degree of equivalence and alternative comparison measures for a range of values of the transfer standard uncertainty relative to the individual laboratory uncertainty values. The proposed alternative criteria successfully discerned between passing, failing, and inconclusive comparison results for the cases we examined. PMID:28090123

[Standardization of operation monitoring and control of the clinical laboratory automation system].

PubMed

Tao, R

2000-10-01

Laboratory automation systems showed up in the 1980s and have been introduced to many clinical laboratories since early 1990s. Meanwhile, it was found that the difference in the specimen tube dimensions, specimen identification formats, specimen carrier transportation equipment architecture, electromechanical interfaces between the analyzers and the automation systems was preventing the systems from being introduced to a wider extent. To standardize the different interfaces and reduce the cost of laboratory automation, NCCLS and JCCLS started establishing standards for laboratory automation in 1996 and 1997 respectively. Operation monitoring and control of the laboratory automation system have been included in their activities, resulting in the publication of an NCCLS proposed standard in 1999.

Identification of bacteria in blood culture broths using matrix-assisted laser desorption-ionization Sepsityper™ and time of flight mass spectrometry.

PubMed

Kok, Jen; Thomas, Lee C; Olma, Thomas; Chen, Sharon C A; Iredell, Jonathan R

2011-01-01

Matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF MS) is a novel method for the direct identification of bacteria from blood culture broths. We evaluate for the first time, the performance of the MALDI Sepsityper™ Kit and MS for the identification of bacteria compared to standard phenotypic methods using the manufacturer's specified bacterial identification criteria (spectral scores ≥1.700-1.999 and ≥2.000 indicated identification to genus and species level, respectively). Five hundred and seven positive blood culture broths were prospectively examined, of which 379 (74.8%; 358 monomicrobial, 21 polymicrobial) were identified by MALDI-TOF MS; 195 (100%) and 132 (67.7%) of 195 gram-positive; and 163 (100%) and 149 (91.4%) of 163 gram-negative organisms from monomicrobial blood cultures were correctly identified to genus and species level, respectively. Spectral scores <1.700 (no identification) were obtained in 128/507 (25.2%) positive blood culture broths, including 31.6% and 32.3% of gram-positive and polymicrobial blood cultures, respectively. Significantly more gram-negative organisms were identified compared to gram-positive organisms at species level (p<0.0001). Five blood cultures were misidentified, but at species level only; including four monomicrobial blood cultures with Streptococcus oralis/mitis that were misidentified as Streptococcus pneumoniae. Positive predictive values for the direct identification of both gram-positive and gram-negative bacteria from monomicrobial blood culture broths to genus level were 100%. A diagnostic algorithm for positive blood culture broths that incorporates gram staining and MALDI-TOF MS should identify the majority of pathogens, particularly to genus level.

Analysis of lard in meatball broth using Fourier transform infrared spectroscopy and chemometrics.

PubMed

Kurniawati, Endah; Rohman, Abdul; Triyana, Kuwat

2014-01-01

Meatball is one of the favorite foods in Indonesia. For the economic reason (due to the price difference), the substitution of beef meat with pork can occur. In this study, FTIR spectroscopy in combination with chemometrics of partial least square (PLS) and principal component analysis (PCA) was used for analysis of pork fat (lard) in meatball broth. Lard in meatball broth was quantitatively determined at wavenumber region of 1018-1284 cm(-1). The coefficient of determination (R(2)) and root mean square error of calibration (RMSEC) values obtained were 0.9975 and 1.34% (v/v), respectively. Furthermore, the classification of lard and beef fat in meatball broth as well as in commercial samples was performed at wavenumber region of 1200-1000 cm(-1). The results showed that FTIR spectroscopy coupled with chemometrics can be used for quantitative analysis and classification of lard in meatball broth for Halal verification studies. The developed method is simple in operation, rapid and not involving extensive sample preparation. © 2013.

Volatile flavor constituents in the pork broth of black-pig.

PubMed

Zhao, Jian; Wang, Meng; Xie, Jianchun; Zhao, Mengyao; Hou, Li; Liang, Jingjing; Wang, Shi; Cheng, Jie

2017-07-01

Pork of black-pig in China is well known for its quality and preferred by consumers. However, there is a lack of research on its flavors. By solvent assisted flavor evaporation combined with GC-MS, 104 volatile compounds in the stewed pork broth of black-pig were identified with the dominant amounts of fatty acids, alcohols, and esters. By aroma extract dilution analysis-GC-O method, 27 odor-active compounds were characterized, including 2-methyl-3-furanthiol, 3-(methylthio)propanal, 2-furfurylthiol, γ-decalactone, nonanal, (E)-2-nonenal, and (E,E)-2,4-decadienal that had high FD factors. Compared to the common white-pig, the aroma compounds in both pork broths were almost the same, but the aroma profile of potent odorants for the black-pig pork broth showed less fatty and more roasted notes, which were partially attributed to the higher monounsaturated fatty acids and lower polyunsaturated fatty acids in meat. With aid of authentic chemicals and selected reaction monitoring mode of GC-MS/MS, 19 aroma compounds were quantitated. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effect of essential oil concentration on the pH of nutrient and Iso-sensitest broth.

PubMed

Hood, J R; Cavanagh, H M A; Wilkinson, J M

2004-11-01

The role of pH on the antimicrobial activity of essential oils has not been well studied. The effect of four essential oils: Backhousia citriodora, Melaleuca alternifolia, Lavandula angustifolia and Santalum spicatum (0.1% to 10%) on the pH of two commonly used media, nutrient broth and Iso-sensitest broth, was therefore undertaken. Small (less than 0.5 pH units) but statistically significant differences between the pH of the two media followed the addition of M. alternifolia, L. angustifolia and S. spicatum essential oil. In general the effect on pH was greatest at higher concentrations and the fall in pH was greatest in the nutrient broth. The addition of B. citriodora essential oil to nutrient broth resulted in a fall in pH from 7.29 +/- 0.02 (no oil) to 5.2 +/- 0.03 (10% oil). This effect was not observed in the Iso-sensitest broth. Copyright 2004 John Wiley & Sons, Ltd.

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group.

PubMed

Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A

2018-05-09

Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.

DOE standard: The Department of Energy Laboratory Accreditation Program for radiobioassay

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1998-12-01

This technical standard describes the US Department of Energy Laboratory Accreditation Program (DOELAP) for Radiobioassay, for use by the US Department of Energy (DOE) and DOE Contractor radiobioassay programs. This standard is intended to be used in conjunction with the general administrative technical standard that describes the overall DOELAP accreditation process--DOE-STD-1111-98, Department of Energy Laboratory Accreditation Program Administration. This technical standard pertains to radiobioassay service laboratories that provide either direct or indirect (in vivo or in vitro) radiobioassay measurements in support of internal dosimetry programs at DOE facilities or for DOE and DOE contractors. Similar technical standards have been developedmore » for other DOELAP dosimetry programs. This program consists of providing an accreditation to DOE radiobioassay programs based on successful completion of a performance-testing process and an on-site evaluation by technical experts. This standard describes the technical requirements and processes specific to the DOELAP Radiobioassay Accreditation Program as required by 10 CFR 835 and as specified generically in DOE-STD-1111-98.« less

Iodine Standard Materials: Preparation and Inter-Laboratory Comparisons

DOE Office of Scientific and Technical Information (OSTI.GOV)

D D Jenson; M L Adamic; J E Olson

The Idaho National Laboratory is preparing to enter the community of AMS practioners who analyze for 129Iodine. We expect to take delivery of a 0.5 MV compact accelerator mass spectrometry system, built by NEC, in the early summer of 2014. The primary mission for this instrument is iodine; it is designed to analyze iodine in the +3 charge state. As part of the acceptance testing for this instrument, both at NEC and on-site in our laboratory, some sort of standard or reference material is needed to verify performance. Appropriate standard materials are not readily available in the commercial marketplace. Smallmore » quantities can sometimes be acquired from other laboratories already engaged in iodine analyses. In the longer-term, meaningful quantities of standard materials are needed for routine use in analyses, and for quality control functions1. We have prepared some standard materials, starting with elemental Woodward iodine and NIST SRM 3231 [Iodine-129 Isotopic Standard (high level)] 10-6 solution. The goal was to make mixtures at the 5x10-10, 5x10-11, 5x10-12 ratio levels, along with some unmodified Woodward, in the chemical form of silver iodide. Approximately twenty grams of each of these mixtures were prepared. The elemental Woodward iodine was dissolved in chloroform, then reduced to iodide using sodium bisulfite in water. At this point the NIST spike material was added, in the form of sodium iodide. The mixed iodides were oxidized back to iodine in chloroform using hydrogen peroxide. This oxidation step was essential for isotopic equilibration of the 127 and 129 atoms. The iodine was reduced to iodide using sodium bisulfite as before. Excess sulfites and sulfates were precipitated with barium nitrate. After decanting, silver nitrate was used to precipitate the desired silver iodide. Once the silver iodide was produced, the material was kept in darkness as much as possible to minimize photo-oxidation. The various mixtures were synthesized independently

Illinois Occupational Skill Standards: Clinical Laboratory Science/Biotechnology Cluster.

ERIC Educational Resources Information Center

Illinois Occupational Skill Standards and Credentialing Council, Carbondale.

This document, which is intended to serve as a guide for workforce preparation program providers, details the Illinois Occupational Skill Standards for clinical laboratory occupations programs. The document begins with a brief overview of the Illinois perspective on occupational skill standards and credentialing, the process used to develop the…

Superparamagnetic poly(methyl methacrylate) beads for nattokinase purification from fermentation broth.

PubMed

Yang, Chengli; Xing, Jianmin; Guan, Yueping; Liu, Huizhou

2006-09-01

An effective method for purification of nattokinase from fermentation broth using magnetic poly(methyl methacrylate) (PMMA) beads immobilized with p-aminobenzamidine was proposed in this study. Firstly, magnetic PMMA beads with a narrow size distribution were prepared by spraying suspension polymerization. Then, they were highly functionalized via transesterification reaction with polyethylene glycol. The surface hydroxyl-modified magnetic beads obtained were further modified with chloroethylamine to transfer the surface amino-modified magnetic functional beads. The morphology and surface functionality of the magnetic beads were examined by scanning electron microscopy and Fourier transform infrared. An affinity ligand, p-aminobenzamidine was covalently immobilized to the amino-modified magnetic beads by the glutaraldehyde method for nattokinase purification directly from the fermentation broth. The purification factor and the recovery of the enzyme activity were found to be 8.7 and 85%, respectively. The purification of nattokinase from fermentation broth by magnetic beads only took 40 min, which shows a very fast purification of nattokinase compared to traditional purification methods.

In vitro antagonistic growth effects of Lactobacillus fermentum and lactobacillus salivarius and their fermentative broth on periodontal pathogens.

PubMed

Chen, Ling-Ju; Tsai, Hsiu-Ting; Chen, Wei-Jen; Hsieh, Chu-Yang; Wang, Pi-Chieh; Chen, Chung-Shih; Wang, Lina; Yang, Chi-Chiang

2012-10-01

As lactobacilli possess an antagonistic growth property, these bacteria may be beneficial as bioprotective agents for infection control. However, whether the antagonistic growth effects are attributed to the lactobacilli themselves or their fermentative broth remains unclear. The antagonistic growth effects of Lactobacillus salivarius and Lactobacillus fermentum as well as their fermentative broth were thus tested using both disc agar diffusion test and broth dilution method, and their effects on periodontal pathogens, including Streptococcus mutans, Streptococcus sanguis, and Porphyromonas gingivalis in vitro at different concentrations and for different time periods were also compared. Both Lactobacillus salivarius and Lactobacillus fermentum and their concentrated fermentative broth were shown to inhibit significantly the growth of Streptococcus mutans, Streptococcus sanguis, and Porphyromonas gingivalis, although different inhibitory effects were observed for different pathogens. The higher the counts of lactobacilli and the higher the folds of concentrated fermentative broth, the stronger the inhibitory effects are observed. The inhibitory effect is demonstrated to be dose-dependent. Moreover, for the lactobacilli themselves, Lactobacillus fermentum showed stronger inhibitory effects than Lactobacillus salivarius. However, the fermentative broth of Lactobacillus fermentum showed weaker inhibitory effects than that of Lactobacillus salivarius. These data suggested that lactobacilli and their fermentative broth exhibit antagonistic growth activity, and consumption of probiotics or their broth containing lactobacilli may benefit oral health.

LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results.

PubMed

Hauser, Ronald George; Quine, Douglas B; Ryder, Alex

2018-02-01

Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, "million") to numerals. Quality control included expert review. We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Standardizing clinical laboratory data for secondary use.

PubMed

Abhyankar, Swapna; Demner-Fushman, Dina; McDonald, Clement J

2012-08-01

Clinical databases provide a rich source of data for answering clinical research questions. However, the variables recorded in clinical data systems are often identified by local, idiosyncratic, and sometimes redundant and/or ambiguous names (or codes) rather than unique, well-organized codes from standard code systems. This reality discourages research use of such databases, because researchers must invest considerable time in cleaning up the data before they can ask their first research question. Researchers at MIT developed MIMIC-II, a nearly complete collection of clinical data about intensive care patients. Because its data are drawn from existing clinical systems, it has many of the problems described above. In collaboration with the MIT researchers, we have begun a process of cleaning up the data and mapping the variable names and codes to LOINC codes. Our first step, which we describe here, was to map all of the laboratory test observations to LOINC codes. We were able to map 87% of the unique laboratory tests that cover 94% of the total number of laboratory tests results. Of the 13% of tests that we could not map, nearly 60% were due to test names whose real meaning could not be discerned and 29% represented tests that were not yet included in the LOINC table. These results suggest that LOINC codes cover most of laboratory tests used in critical care. We have delivered this work to the MIMIC-II researchers, who have included it in their standard MIMIC-II database release so that researchers who use this database in the future will not have to do this work. Published by Elsevier Inc.

Recovery of butanol from fermentation broth by pervaporation

USDA-ARS?s Scientific Manuscript database

Butanol can be produced by fermentation from corn, molasses or lignocellulosic biomass for use as a chemical or superior biofuel. However, butanol’s production is hampered by its toxicity to the microbial culture that produces it. In fermentation broths, final butanol concentrations typically range ...

Dried-bonito aroma components enhance salivary hemodynamic responses to broth tastes detected by near-infrared spectroscopy.

PubMed

Matsumoto, Tomona; Saito, Kana; Nakamura, Akio; Saito, Tsukasa; Nammoku, Takashi; Ishikawa, Masashi; Mori, Kensaku

2012-01-25

To elucidate the effects of aroma from dried bonito (katsuo-bushi) on broth tastes caused by the central integration of flavor, optical imaging of salivary hemodynamic responses was conducted using near-infrared spectroscopy (NIRS). A reconstituted dried bonito flavored broth produced a significantly larger hemodynamic response than the odorless broth taste solutions for 5 of the 10 panelists, who felt that the combination of the aroma with the tastes was congruent. In the remaining 5 panelists who felt the combination incongruent, the flavored broth did not cause the enhancement of response. Moreover, when the odor-active smoky parts were removed from the flavoring, the reconstituted flavoring did not enhance the response in the former five panelists. These results indicate that NIRS offers a sensitive method to detect the effect of specific congruent aroma components from dried-bonito broth on the taste-related salivary hemodynamic responses, dependent on the perceptual experience of the combination of aromas and tastes.

Report on the Project for Establishment of the Standardized Korean Laboratory Terminology Database, 2015.

PubMed

Jung, Bo Kyeung; Kim, Jeeyong; Cho, Chi Hyun; Kim, Ju Yeon; Nam, Myung Hyun; Shin, Bong Kyung; Rho, Eun Youn; Kim, Sollip; Sung, Heungsup; Kim, Shinyoung; Ki, Chang Seok; Park, Min Jung; Lee, Kap No; Yoon, Soo Young

2017-04-01

The National Health Information Standards Committee was established in 2004 in Korea. The practical subcommittee for laboratory test terminology was placed in charge of standardizing laboratory medicine terminology in Korean. We aimed to establish a standardized Korean laboratory terminology database, Korea-Logical Observation Identifier Names and Codes (K-LOINC) based on former products sponsored by this committee. The primary product was revised based on the opinions of specialists. Next, we mapped the electronic data interchange (EDI) codes that were revised in 2014, to the corresponding K-LOINC. We established a database of synonyms, including the laboratory codes of three reference laboratories and four tertiary hospitals in Korea. Furthermore, we supplemented the clinical microbiology section of K-LOINC using an alternative mapping strategy. We investigated other systems that utilize laboratory codes in order to investigate the compatibility of K-LOINC with statistical standards for a number of tests. A total of 48,990 laboratory codes were adopted (21,539 new and 16,330 revised). All of the LOINC synonyms were translated into Korean, and 39,347 Korean synonyms were added. Moreover, 21,773 synonyms were added from reference laboratories and tertiary hospitals. Alternative strategies were established for mapping within the microbiology domain. When we applied these to a smaller hospital, the mapping rate was successfully increased. Finally, we confirmed K-LOINC compatibility with other statistical standards, including a newly proposed EDI code system. This project successfully established an up-to-date standardized Korean laboratory terminology database, as well as an updated EDI mapping to facilitate the introduction of standard terminology into institutions. © 2017 The Korean Academy of Medical Sciences.

International standards for tuberculosis care: relevance and implications for laboratory professionals.

PubMed

Pai, M; Daley, P; Hopewell, P C

2007-04-01

On World Tuberculosis (TB) Day 2006, the International Standards for Tuberculosis Care (ISTC) was officially released and widely endorsed by several agencies and organizations. The ISTC release was the culmination of a year long global effort to develop and set internationally acceptable, evidence-based standards for tuberculosis care. The ISTC describes a widely endorsed level of care that all practitioners, public and private, should seek to achieve in managing individuals who have or are suspected of having, TB and is intended to facilitate the effective engagement of all healthcare providers in delivering high quality care for patients of all ages, including those with smear-positive, smear-negative and extra-pulmonary TB, TB caused by drug-resistant Mycobacterium tuberculosis and TB/HIV coinfection. In this article, we present the ISTC, with a special focus on the diagnostic standards and describe their implications and relevance for laboratory professionals in India and worldwide. Laboratory professionals play a critical role in ensuring that all the standards are actually met by providing high quality laboratory services for smear microscopy, culture and drug susceptibility testing and other services such as testing for HIV infection. In fact, if the ISTC is widely followed, it can be expected that there will be a greater need and demand for quality assured laboratory services and this will have obvious implications for all laboratories in terms of work load, requirement for resources and trained personnel and organization of quality assurance systems.

Comparison between Bactec Peds Plus F Broth and Conventional Medium for Vitreous Culture.

PubMed

Tabatabaei, Seyed Ali; Tabatabaei, Seyed Mehdi; Soleimani, Mohammad; Hejrati, Bahman; Mirshahi, Ahmad; Khadabandeh, Alireza; Ahmadraji, Aliasghar; Valipour, Niloofar

2018-05-10

To evaluate the yield of Bactec Peds Plus F broth for vitreous sample culture in cases with infectious endophthalmitis in comparison to conventional medium. Consecutive cases of clinically suspected endophthalmitis were prospectively enrolled in this study. Cultures of the vitreous sample were performed in both Bactec Peds Plus F broth and conventional mediums. Forty eyes of 40 patients who were clinically suspected of infectious endophthalmitis with different etiologies were enrolled in this study. The positive culture yield was 50% and 35% in Bactec Peds Plus F broth and conventional mediums, respectively (p = 0.07). The result of Bactec group was not significantly different among patients who had a history of intravitreal antibiotic injection (p > 0.05) (Table 2). However, results of the conventional method were significantly negative in the previous intravitreal antibiotic injection group (p = 0.02). There was no correlation between the methods of vitreous sampling in both culture methods. Although the difference between two culture methods was not statistically significant in this study, Bactec Peds Plus F broth showed higher positive culture yield in patients with a history of intravitreal antibiotic injection.

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2014 CFR

2014-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 26 2014-07-01 2014-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2012 CFR

2012-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 27 2012-07-01 2012-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2013 CFR

2013-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 27 2013-07-01 2013-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2011 CFR

2011-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 26 2011-07-01 2011-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

Detection of Listeria monocytogenes from selective enrichment broth using MALDI-TOF Mass Spectrometry.

PubMed

Jadhav, Snehal; Sevior, Danielle; Bhave, Mrinal; Palombo, Enzo A

2014-01-31

Conventional methods used for primary detection of Listeria monocytogenes from foods and subsequent confirmation of presumptive positive samples involve prolonged incubation and biochemical testing which generally require four to five days to obtain a result. In the current study, a simple and rapid proteomics-based MALDI-TOF MS approach was developed to detect L. monocytogenes directly from selective enrichment broths. Milk samples spiked with single species and multiple species cultures were incubated in a selective enrichment broth for 24h, followed by an additional 6h secondary enrichment. As few as 1 colony-forming unit (cfu) of L. monocytogenes per mL of initial selective broth culture could be detected within 30h. On applying the same approach to solid foods previously implicated in listeriosis, namely chicken pâté, cantaloupe and Camembert cheese, detection was achieved within the same time interval at inoculation levels of 10cfu/mL. Unlike the routine application of MALDI-TOF MS for identification of bacteria from solid media, this study proposes a cost-effective and time-saving detection scheme for direct identification of L. monocytogenes from broth cultures.This article is part of a Special Issue entitled: Trends in Microbial Proteomics. Globally, foodborne diseases are major causes of illness and fatalities in humans. Hence, there is a continual need for reliable and rapid means for pathogen detection from food samples. Recent applications of MALDI-TOF MS for diagnostic microbiology focused on detection of microbes from clinical specimens. However, the current study has emphasized its use as a tool for detecting the major foodborne pathogen, Listeria monocytogenes, directly from selective enrichment broths. This proof-of-concept study proposes a detection scheme that is more rapid and simple compared to conventional methods of Listeria detection. Very low levels of the pathogen could be identified from different food samples post-enrichment in

The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system.

PubMed

Massambu, Charles; Mwangi, Christina

2009-06-01

The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process.

Fermentation broth components influence droplet coalescence and hinder advanced biofuel recovery during fermentation.

PubMed

Heeres, Arjan S; Schroën, Karin; Heijnen, Joseph J; van der Wielen, Luuk A M; Cuellar, Maria C

2015-08-01

Developments in synthetic biology enabled the microbial production of long chain hydrocarbons, which can be used as advanced biofuels in aviation or transportation. Currently, these fuels are not economically competitive due to their production costs. The current process offers room for improvement: by utilizing lignocellulosic feedstock, increasing microbial yields, and using cheaper process technology. Gravity separation is an example of the latter, for which droplet growth by coalescence is crucial. The aim of this study was to study the effect of fermentation broth components on droplet coalescence. Droplet coalescence was measured using two setups: a microfluidic chip and regular laboratory scale stirred vessel (2 L). Some fermentation broth components had a large impact on droplet coalescence. Especially components present in hydrolysed cellulosic biomass and mannoproteins from the yeast cell wall retard coalescence. To achieve a technically feasible gravity separation that can be integrated with the fermentation, the negative effects of these components on coalescence should be minimized. This could be achieved by redesign of the fermentation medium or adjusting the fermentation conditions, aiming to minimize the release of surface active components by the microorganisms. This way, another step can be made towards economically feasible advanced biofuel production. © 2015 The Authors. Biotechnology Journal published by Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim. This is an open access article under the terms of the Creative Commons Attribution-Non-Commercial-NoDerivs Licence, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Influence of enrichment broths on multiplex PCR detection of total coliform bacteria, Escherichia coli and Clostridium perfringens, in spiked water samples.

PubMed

Worakhunpiset, S; Tharnpoophasiam, P

2009-07-01

Although multiplex PCR amplification condition for simultaneous detection of total coliform bacteria, Escherichia coli and Clostridium perfringens in water sample has been developed, results with high sensitivity are obtained when amplifying purified DNA, but the sensitivity is low when applied to spiked water samples. An enrichment broth culture prior PCR analysis increases sensitivity of the test but the specific nature of enrichment broth can affect the PCR results. Three enrichment broths, lactose broth, reinforced clostridial medium and fluid thioglycollate broth, were compared for their influence on sensitivity and on time required with multiplex PCR assay. Fluid thioglycollate broth was the most effective with shortest enrichment time and lowest detection limit.

Inter-laboratory comparison study on measuring semi-volatile organic chemicals in standards and air samples.

PubMed

Su, Yushan; Hung, Hayley

2010-11-01

Measurements of semi-volatile organic chemicals (SVOCs) were compared among 21 laboratories from 7 countries through the analysis of standards, a blind sample, an air extract, and an atmospheric dust sample. Measurement accuracy strongly depended on analytes, laboratories, and types of standards and samples. Intra-laboratory precision was generally good with relative standard deviations (RSDs) of triplicate injections <10% and with median differences of duplicate samples between 2.1 and 22%. Inter-laboratory variability, measured by RSDs of all measurements, was in the range of 2.8-58% in analyzing standards, and 6.9-190% in analyzing blind sample and air extract. Inter-laboratory precision was poorer when samples were subject to cleanup processes, or when SVOCs were quantified at low concentrations. In general, inter-laboratory differences up to a factor of 2 can be expected to analyze atmospheric SVOCs. When comparing air measurements from different laboratories, caution should be exercised if the data variability is less than the inter-laboratory differences. 2010. Published by Elsevier Ltd. All rights reserved.

42 CFR 493.1359 - Standard; PPM laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for... subparts H, J, K, and M of this part. [57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3713, Jan. 24, 2003...

A report from the AVS Standards Committee - Comparison of ion gauge calibrations by several standards laboratories

NASA Technical Reports Server (NTRS)

Warshawsky, I.

1982-01-01

Calibrations by four U.S. laboratories of four hot-cathode ion gauges, in the range 0.07-13 mPa, showed systematic differences among laboratories that were much larger than the expected error of any one calibration. They also suggested that any of the four gauges tested, if properly packaged and shipped, was able to serve as a transfer standard with probable error of 2%. A second comparison was made of the calibrations by two U.S. laboratories of some other gauges that had also been calibrated by the National Physical Laboratory, England. Results did not permit conclusive determination of whether differences were due to the laboratories or to changes in the gauges.

Productivity standards for histology laboratories.

PubMed

Buesa, René J

2010-04-01

The information from 221 US histology laboratories (histolabs) and 104 from 24 other countries with workloads from 600 to 116 000 cases per year was used to calculate productivity standards for 23 technical and 27 nontechnical tasks and for 4 types of work flow indicators. The sample includes 254 human, 40 forensic, and 31 veterinary pathology services. Statistical analyses demonstrate that most productivity standards are not different between services or worldwide. The total workload for the US human pathology histolabs averaged 26 061 cases per year, with 54% between 10 000 and less than 30 000. The total workload for 70% of the histolabs from other countries was less than 20 000, with an average of 15 226 cases per year. The fundamental manual technical tasks in the histolab and their productivity standards are as follows: grossing (14 cases per hour), cassetting (54 cassettes per hour), embedding (50 blocks per hour), and cutting (24 blocks per hour). All the other tasks, each with their own productivity standards, can be completed by auxiliary staff or using automatic instruments. Depending on the level of automation of the histolab, all the tasks derived from a workload of 25 cases will require 15.8 to 17.7 hours of work completed by 2.4 to 2.7 employees with 18% of their working time not directly dedicated to the production of diagnostic slides. This article explains how to extrapolate this productivity calculation for any workload and different levels of automation. The overall performance standard for all the tasks, including 8 hours for automated tissue processing, is 3.2 to 3.5 blocks per hour; and its best indicator is the value of the gross work flow productivity that is essentially dependent on how the work is organized. This article also includes productivity standards for forensic and veterinary histolabs, but the staffing benchmarks for histolabs will be the subject of a separate article. Copyright 2010 Elsevier Inc. All rights reserved.

Improving Consistency in Large Laboratory Courses: A Design for a Standardized Practical Exam

ERIC Educational Resources Information Center

Chen, Xinnian; Graesser, Donnasue; Sah, Megha

2015-01-01

Laboratory courses serve as important gateways to science, technology, engineering, and mathematics education. One of the challenges in assessing laboratory learning is to conduct meaningful and standardized practical exams, especially for large multisection laboratory courses. Laboratory practical exams in life sciences courses are frequently…

Illinois Occupational Skill Standards: Agricultural Laboratory and Field Technician Cluster.

ERIC Educational Resources Information Center

Illinois Occupational Skill Standards and Credentialing Council, Carbondale.

These Illinois skill standards for the agricultural laboratory and field technician cluster are intended to serve as a guide to workforce preparation program providers as they define content for their programs and to employers as they establish the skills and standards necessary for job acquisition. They could also serve as a mechanism for…

[Determination of sugars, organic acids and alcohols in microbial consortium fermentation broth from cellulose using high performance liquid chromatography].

PubMed

Jiang, Yan; Fan, Guifang; Du, Ran; Li, Peipei; Jiang, Li

2015-08-01

A high performance liquid chromatographic method was established for the determination of metabolites (sugars, organic acids and alcohols) in microbial consortium fermentation broth from cellulose. Sulfate was first added in the samples to precipitate calcium ions in microbial consortium culture medium and lower the pH of the solution to avoid the dissociation of organic acids, then the filtrates were effectively separated using high performance liquid chromatography. Cellobiose, glucose, ethanol, butanol, glycerol, acetic acid and butyric acid were quantitatively analyzed. The detection limits were in the range of 0.10-2.00 mg/L. The linear correlation coefficients were greater than 0.999 6 in the range of 0.020 to 1.000 g/L. The recoveries were in the range of 85.41%-115.60% with the relative standard deviations of 0.22% -4.62% (n = 6). This method is accurate for the quantitative analysis of the alcohols, organic acids and saccharides in microbial consortium fermentation broth from cellulose.

Comparison of antimicrobial susceptibilities of Corynebacterium species by broth microdilution and disk diffusion methods.

PubMed Central

Weiss, K; Laverdière, M; Rivest, R

1996-01-01

Corynebacterium species are increasingly being implicated in foreign-body infections and in immunocompromised-host infections. However, there are no specific recommendations on the method or the criteria to use in order to determine the in vitro activities of the antibiotics commonly used to treat Corynebacterium infections. The first aim of our study was to compare the susceptibilities of various species of Corynebacterium to vancomycin, erythromycin, and penicillin by using a broth microdilution method and a disk diffusion method. Second, the activity of penicillin against our isolates was assessed by using the interpretative criteria recommended by the National Committee for Clinical Laboratory Standards for the determination of the susceptibility of streptococci and Listeria monocytogenes to penicillin. Overall, 100% of the isolates were susceptible to vancomycin, while considerable variations in the activities of erythromycin and penicillin were noted for the different species tested, including the non-Corynebacterium jeikeium species. A good correlation in the susceptibilities of vancomycin and erythromycin between the disk diffusion and the microdilution methods was observed. However, a 5% rate of major or very major errors was detected with the Listeria criteria, while a high rate of minor errors (18%) was noted when the streptococcus criteria were used. Our findings indicate considerable variations in the activities of erythromycin and penicillin against the various species of Corynebacterium. Because of the absence of definite recommendations, important discrepancies were observed between the methods and the interpretations of the penicillin activity. PMID:8849254

U.S. Geological Survey Standard Reference Sample Project: Performance Evaluation of Analytical Laboratories

USGS Publications Warehouse

Long, H. Keith; Daddow, Richard L.; Farrar, Jerry W.

1998-01-01

Since 1962, the U.S. Geological Survey (USGS) has operated the Standard Reference Sample Project to evaluate the performance of USGS, cooperator, and contractor analytical laboratories that analyze chemical constituents of environmental samples. The laboratories are evaluated by using performance evaluation samples, called Standard Reference Samples (SRSs). SRSs are submitted to laboratories semi-annually for round-robin laboratory performance comparison purposes. Currently, approximately 100 laboratories are evaluated for their analytical performance on six SRSs for inorganic and nutrient constituents. As part of the SRS Project, a surplus of homogeneous, stable SRSs is maintained for purchase by USGS offices and participating laboratories for use in continuing quality-assurance and quality-control activities. Statistical evaluation of the laboratories results provides information to compare the analytical performance of the laboratories and to determine possible analytical deficiences and problems. SRS results also provide information on the bias and variability of different analytical methods used in the SRS analyses.

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

Sugaring-out extraction of acetoin from fermentation broth by coupling with fermentation.

PubMed

Dai, Jian-Ying; Ma, Lin-Hui; Wang, Zhuang-Fei; Guan, Wen-Tian; Xiu, Zhi-Long

2017-03-01

Acetoin is a natural flavor and an important bio-based chemical which could be separated from fermentation broth by solvent extraction, salting-out extraction or recovered in the form of derivatives. In this work, a novel method named as sugaring-out extraction coupled with fermentation was tried in the acetoin production by Bacillus subtilis DL01. The effects of six solvents on bacterial growth and the distribution of acetoin and glucose in different solvent-glucose systems were explored. The operation parameters such as standing time, glucose concentration, and volume ratio of ethyl acetate to fermentation broth were determined. In a system composed of fermentation broth, glucose (100%, m/v) and two-fold volume of ethyl acetate, nearly 100% glucose was distributed into bottom phase, and 61.2% acetoin into top phase without coloring matters and organic acids. The top phase was treated by vacuum distillation to remove solvent and purify acetoin, while the bottom phase was used as carbon source to produce acetoin in the next batch of fermentation.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

PubMed

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-03-26

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

Xanthan gum recovery from fermentation broth using ultrafiltration: Kinetics and process evaluation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lo, Y.M.; Yang, S.T.; Min, D.B.

1995-12-01

Ultrafiltration of xanthan gum solution as an alternative method to alcohol precipitation for xanthan gum recovery from dilute fermentation broth was studied. A polysulfone membrane (with 500,000 MWCO) hollow fiber (106 mil fiber diameter) tubular cartridge was used to concentrate xanthan broth from less than 3 (w/v) % to {approximately}13.5 (w/v) %, with the xanthan recovery yield of {approximately}95 % or higher. During ultrafiltration, the filtrate flux was one order of magnitude lower for xanthan broth than for water, However, the flux remained almost constant for xanthan concentrations up to {approximately}8%. It was then reduced dramatically as the xanthan concentrationmore » increased beyond 8%. The reduced filtrate flux was caused by the reduced pumping (shear) rate and higher viscosities at higher xanthan concentrations. At constant xanthan concentration, the filtrate flux remained almost unchanged for the entire period studied, suggesting that the process is not subject to membrane fouling. In general, the filtrate flux decreased with increasing the xanthan concentration and increased with increasing the pumping (shear) rate and the trans-membrane pressure difference. Changing the solution pH had a slight effect on the viscosity of xanthan solution, but did not affect the filtration performance. Even under high-shear-rate conditions, ultrafiltration did not give any adverse effects on the rheological properties and molecular weight of the xanthan polymer. Thus, ultra filtration can be used to concentrate xanthan broth from fermentation by a factor of four or higher and to reduce the subsequent alcohol recovery costs by at least 75 %.« less

Development of a Novel Listeria Enrichment Broth for the Isolation of Pathogenic Listeria.

PubMed

Liu, Dongxin; Wang, Yan; Wang, Yi; Zhang, Lu; Luo, Lijuan; Liu, Kai; Ye, Changyun

2017-10-01

Listeriosis, the disease caused by pathogenic Listeria species, can present severe symptoms in susceptible people. The goal of this study was to develop a novel enrichment broth, Listeria allose enrichment broth (LAEB), to improve isolation of Listeria monocytogenes and Listeria ivanovii from samples through incorporating a specific carbohydrate and reducing inhibitor concentrations. Other coexisting bacteria, particularly Listeria innocua, can interfere with the isolation of pathogenic Listeria in such ways as overgrowth of L. innocua and the generation of inhibitory metabolites. The incorporation of allose into the novel LAEB was effective for slowing the growth of L. innocua and other nontarget microorganisms. We determined that 35°C and pH 7.0 under aerobic conditions are optimal for Listeria growth in this medium. The novelty of the use of LAEB is the single enrichment procedure at 35°C for 24 h, obviating the need for a secondary enrichment medium. In 50 simulated samples, the sensitivity of the LAEB method (86%) was higher than that of the International Organization for Standardization (EN ISO) method (70%). In 142 naturally contaminated samples tested, the isolation rate for pathogenic Listeria with the LAEB method was 26.0% (37 of 142 samples), which was significantly higher than the 17.6% (25 of 142 samples) for the EN ISO method. Higher isolation rates and a quicker and easier protocol make the novel LAEB method an appropriate alternative for the isolation of pathogenic Listeria.

The standardization of urine particle counting in medical laboratories--a Polish experience with the EQA programme.

PubMed

Cwiklińska, Agnieszka; Kąkol, Judyta; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Pacanis, Anastasis; Rogulski, Jerzy; Wróblewska, Małgorzata

2012-02-01

Given the common problems with the standardization of urine particle counting methods and the great variability in the results obtained by Polish laboratories under international Labquality External Quality Assessment (EQA), we initiated educational recovery activities. Detailed instructions on how to perform the standardized examination were sent to EQA participants, as was a questionnaire forms which enabled information to be gathered in respect to the procedures being applied. Laboratory results were grouped according to the method declared on the EQA 'Result' form or according to a manual examination procedure established on the basis of the questionnaire. The between-laboratory CVs for leukocyte and erythrocyte counts were calculated for each group and compared using the Mann-Whitney test. Significantly lower between-laboratory CVs (p = 0.03) were achieved for leukocyte counting among the laboratories that analysed control specimens in accordance with standardized procedures as compared with those which used non-standardized procedures. We also observed a visible lower variability for erythrocyte counting. Unfortunately despite our activities, only a few of the Polish laboratories applied the standardized examination procedures, and only 29% of the results could have been considered to be standardized (16% - manual methods, 13% - automated systems). The standardization of urine particle counting methods continues to be a significant problem in medical laboratories and requires further recovery activities which can be conducted using the EQA scheme.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

PubMed Central

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-01-01

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

Supplementing chicken broth with monosodium glutamate reduces energy intake from high fat and sweet snacks in middle-aged healthy women.

PubMed

Imada, Toshifumi; Hao, Susan Shuzhen; Torii, Kunio; Kimura, Eiichiro

2014-08-01

Monosodium L-glutamate (MSG) and inosine monophosphate-5 (IMP) are flavor enhancers for umami taste. However, their effects on appetite and food intake are not well-researched. The objective of the current study was to test their additions in a broth preload on subsequent appetite ratings, energy intake and food choice. Eighty-six healthy middle-aged women with normal body weight received three preload conditions on 3 test days 1 week apart - a low-energy chicken flavor broth (200 ml) as the control preload, and broths with added MSG alone (0.5 g/100 ml, MSG broth) or in combination with IMP (0.05 g/100 ml) (MSG+ broth) served as the experimental conditions. Fifteen minutes after preload administration subjects were provided an ad libitum testing meal which consisted of 16 snacks varying in taste and fat content. MSG and MSG+ enhanced savory taste and broth properties of liking and pleasantness. In comparison with control, the MSG preload resulted in less consumption of total energy, as well as energy from sweet and high-fat snacks. Furthermore, MSG broth preload reduced added sugar intake. These findings were not observed after MSG+ preload. Appetite ratings were not different across the three preloads. Results suggest a potential role of MSG addition to a low-energy broth preload in subsequent energy intake and food choice. This trial was registered at clinicaltrials.gov as NCT01761045. Copyright © 2014 Elsevier Ltd. All rights reserved.

Production of High-Viscosity Whey Broths by a Lactose-Utilizing Xanthomonas campestris Strain.

PubMed

Schwartz, R D; Bodie, E A

1985-12-01

Xanthomonas campestris BB-1L was isolated by enrichment and selection by serial passage in a lactose-minimal medium. When BB-1L was subsequently grown in medium containing only 4% whey and 0.05% yeast extract, the lactose was consumed and broth viscosities greater than 500 cps at a 12 s shear rate were produced. Prolonged maintenance in whey resulted in the loss of the ability of BB-1L to produce viscous broths in whey, indicating a reversion to preferential growth on whey protein, like the parent strain.

Production of High-Viscosity Whey Broths by a Lactose-Utilizing Xanthomonas campestris Strain

PubMed Central

Schwartz, Robert D.; Bodie, Elizabeth A.

1985-01-01

Xanthomonas campestris BB-1L was isolated by enrichment and selection by serial passage in a lactose-minimal medium. When BB-1L was subsequently grown in medium containing only 4% whey and 0.05% yeast extract, the lactose was consumed and broth viscosities greater than 500 cps at a 12 s−1 shear rate were produced. Prolonged maintenance in whey resulted in the loss of the ability of BB-1L to produce viscous broths in whey, indicating a reversion to preferential growth on whey protein, like the parent strain. PMID:16346946

Quality, antioxidative ability, and cell proliferation-enhancing activity of fermented black soybean broths with various supplemental culture medium.

PubMed

Lin, Chih-Chien; Wu, Pey-Shiuan; Liang, David Woei-Ming; Kwan, Chang-Chin; Chen, Yi-Shyan

2012-01-01

The fermented soybean-based foods have played an important role in traditional diets around the world for many centuries, and Bacillus subtilis is typically used in the fermentation of soybean-based foods. The fermentation process may improve not only the flavor but also the nutritional value of food, and substances produced in this fermented broth were affected by many factors including culture medium and the selected soybeans. In this study, we use 3 potential culture mediums in the fermentation of black soybean and the fermented black soybean broths were used for the examination of amino acid composition, total phenolics content, flavonoids and anthocyanins contents, the antioxidant properties, and cytotoxicity. Our results indicated that the fermented black soybean broth, fermentation III, have the most abundant essential amino acid (79.77 mg/g), phenolics (19.33 mg/g), flavonoids (46.01 mg/g), and anthocyanins (1.06 mg/g). Besides, all of the fermented black soybean broths exhibited the significant antioxidative abilities with 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical scavenging effect, reducing power and ferrous ion chelating effect. In addition, the fermented black soybean broths demonstrated the cell proliferation-enhancing activity in Detroit 551 cells. The cells were augmented up to the maximum value of 183.6% (compared with control) at 10 mg/mL of the fermentation I. Therefore, the different supplemental culture medium fermented black soybean broths may be used as a functional ingredient in the products of nutritional drinks and health foods. The present study illustrated the potential of various supplemental culture medium fermented black soybean broths in the application of functional ingredient for nutritional drinks and health foods. © 2011 Institute of Food Technologists®

76 FR 72216 - Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-22

... by developing a written Chemical Hygiene Plan (CHP) that describes standard operating procedures for...] Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of Management... requirements specified in the Standard on Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR...

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE (NELAC): CONSTITUTION, BYLAWS, AND STANDARDS

EPA Science Inventory

The principles and operating procedures for the National Environmental Laboratory Accreditation Conference (NELAC) are contained in the NELAC Constitution and Bylaws. The major portion of this document (standards) contains detailed requirements for accrediting environmental labo...

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

PubMed

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Quality assurance of reference standards from nine European solar-ultraviolet monitoring laboratories.

PubMed

Gröbner, Julian; Rembges, Diana; Bais, Alkiviadis F; Blumthaler, Mario; Cabot, Thierry; Josefsson, Weine; Koskela, Tapani; Thorseth, Trond M; Webb, Ann R; Wester, Ulf

2002-07-20

A program for quality assurance of reference standards has been initiated among nine solar-UV monitoring laboratories. By means of a traveling lamp package that comprises several 1000-W ANSI code DXW-type quartz-halogen lamps, a 0.1-ohm shunt, and a 6-1/2 digit voltmeter, the irradiance scales used by the nine laboratories were compared with one another; a relative uncertainty of 1.2% was found. The comparison of 15 reference standards yielded differences of as much as 9%; the average difference was less than 3%.

Food intake in laboratory rats provided standard and fenbendazole-supplemented diets.

PubMed

Vento, Peter J; Swartz, Megan E; Martin, Lisa Be; Daniels, Derek

2008-11-01

The benzimidazole anthelmintic fenbendazole (FBZ) is a common and effective treatment for pinworm infestation in laboratory animal colonies. Although many investigators have examined the potential for deleterious biologic effects of FBZ, more subtle aspects of the treatment remain untested. Accordingly, we evaluated differences in food intake when healthy male Sprague-Dawley rats were provided a standard nonmedicated laboratory rodent chow or the same chow supplemented with FBZ. We also tested for a preference for either food type when subjects were provided a choice of the 2 diets. Data from these experiments showed no differences in food intake or body weight when rats were maintained on either standard or FBZ-supplemented chow. When the rats were given access to both the standard and FBZ-supplemented diets, they showed a clear preference for the standard diet. The preference for the standard diet indicates that the rats can discriminate between the 2 foods and may avoid the FBZ-supplemented chow when possible. Investigators conducting experiments during treatment with FBZ in which differences in food preference are relevant should be aware of these data and plan their studies accordingly.

Food Intake in Laboratory Rats Provided Standard and Fenbendazole-supplemented Diets

PubMed Central

Vento, Peter J; Swartz, Meghan E; Martin, Lisa BE; Daniels, Derek

2008-01-01

The benzimidazole anthelmintic fenbendazole (FBZ) is a common and effective treatment for pinworm infestation in laboratory animal colonies. Although many investigators have examined the potential for deleterious biologic effects of FBZ, more subtle aspects of the treatment remain untested. Accordingly, we evaluated differences in food intake when healthy male Sprague–Dawley rats were provided a standard nonmedicated laboratory rodent chow or the same chow supplemented with FBZ. We also tested for a preference for either food type when subjects were provided a choice of the 2 diets. Data from these experiments showed no differences in food intake or body weight when rats were maintained on either standard or FBZ-supplemented chow. When the rats were given access to both the standard and FBZ-supplemented diets, they showed a clear preference for the standard diet. The preference for the standard diet indicates that the rats can discriminate between the 2 foods and may avoid the FBZ-supplemented chow when possible. Investigators conducting experiments during treatment with FBZ in which differences in food preference are relevant should be aware of these data and plan their studies accordingly. PMID:19049253

[The analytical reliability of clinical laboratory information and role of the standards in its support].

PubMed

Men'shikov, V V

2012-12-01

The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

Perirectal Swab Surveillance for Clostridium difficile by Use of Selective Broth Preamplification and Real-Time PCR Detection of tcdB ▿

PubMed Central

Curry, Scott R.; Schlackman, Jessica L.; Hamilton, Travis M.; Henderson, Tatianna K.; Brown, Nakita T.; Marsh, Jane W.; Shutt, Kathleen A.; Brooks, Maria M.; Pasculle, A. William; Muto, Carlene A.; Harrison, Lee H.

2011-01-01

Active surveillance testing to identify and isolate asymptomatic carriers of toxigenic Clostridium difficile has been limited by the lack of a test that is sensitive, specific, and timely enough to serve as an infection control tool. We tested DNA preamplified from perirectal surveillance specimens in a liquid medium selective for C. difficile by using a modified commercial real-time PCR assay. All fermenting specimens were subcultured, and isolates were tested for toxigenicity. Culture-positive toxigenic isolates served as the gold standard for comparison with the broth preamplification/PCR assay. The limit of detection for the assay was 1 CFU. Relative to toxigenic anaerobic culture, the sensitivity, specificity, and positive and negative predictive values of this assay were 70/70 (100.0%), 422/426 (99.1%), 70/74 (94.6%), and 422/422 (100.0%), respectively. These data demonstrate that selective broth preamplification and real-time PCR of perirectal swab specimens constitute a practical approach to the detection of asymptomatic C. difficile carriage. PMID:21880961

Removal of heavy metals from polluted soil using the citric acid fermentation broth: a promising washing agent.

PubMed

Zhang, Hongjiao; Gao, Yuntao; Xiong, Huabin

2017-04-01

The citric acid fermentation broth was prepared and it was employed to washing remediation of heavy metal-polluted soil. A well-defined washing effect was obtained, the removal percentages using citric acid fermentation broth are that 48.2% for Pb, 30.6% for Cu, 43.7% for Cr, and 58.4% for Cd and higher than that using citric acid solution. The kinetics of heavy metals desorption can be described by the double constant equation and Elovich equation and is a heterogeneous diffusion process. The speciation analysis shows that the citric acid fermentation broth can effectively reduce bioavailability and environmental risk of heavy metals. Spectroscopy characteristics analysis suggests that the washing method has only a small effect on the mineral composition and does not destroy the framework of soil system. Therefore, the citric acid fermentation broth is a promising washing agent and possesses a potential practical application value in the field of remediation of soils with a good washing performance.

[[Medicinal broths in the books by Nicolas Lemery, a reflection of scientific developments?

PubMed

Motte-Florac, Élisabeth

2016-03-01

From Ancient times, medicinal broths have been an integral part of the diet fed to patients and convalescents. At the end of 17th century, medical and pharmaceutical knowledge and practices were to enter a period of major upheavals. Although also hitherto discredited, chemical drugs became all the rage, work in chemistry boomed and broths benefited. Do the first editions of the works of Nicolas Lemery reflect the knowledge of his time ? Do last editions – revised, corrected, annotated and completed – really reflect transformations in scientific disciplines, technological developments, and scientific advances, particularly in chemistry?

The evaluation of hospital laboratory information management systems based on the standards of the American National Standard Institute

PubMed Central

Isfahani, Sakineh Saghaeiannejad; Khajouei, Reza; Jahanbakhsh, Maryan; Mirmohamadi, Mahboubeh

2014-01-01

Introduction: Nowadays, modern laboratories are faced with a huge volume of information. One of the goals of the Laboratory Information Management System (LIMS) is to assist in the management of the information generated in the laboratory. This study intends to evaluate the LIMS based on the standards of the American National Standard Institute (ANSI). Materials and Methods: This research is a descriptive–analytical study, which had been conducted in 2011, on the LIMSs in use, in the teaching and private hospitals in Isfahan. The data collecting instrument was a checklist, which was made by evaluating three groups of information components namely: ‘System capabilities’, ‘work list functions,’ and ‘reporting’ based on LIS8-A. Data were analyzed using the SPSS 20. Data were analyzed using (relative) frequency, percentage. To compare the data the following statistical tests were used: Leven test, t-test, and Analysis of Variance (ANOVA). Results: The results of the study indicated that the LIMS had a low conformity (30%) with LIS8-A (P = 0.001), with no difference between teaching and private hospitals (P = 0.806). The ANOVA revealed that in terms of conformity with the LIS8-A standard, there was a significant difference between the systems produced by different vendors (P = 0.023). According to the results, a Kowsar system with more than %57 conformity in the three groups of information components had a better conformity to the standard, compared to the other systems. Conclusions: This study indicated that none of the LIMSs had a good conformity to the standard. It seems that system providers did not pay sufficient attention to many of the information components required by the standards when designing and developing their systems. It was suggested that standards from certified organizations and institutions be followed in the design and development process of health information systems. PMID:25077154

The evaluation of hospital laboratory information management systems based on the standards of the American National Standard Institute.

PubMed

Isfahani, Sakineh Saghaeiannejad; Khajouei, Reza; Jahanbakhsh, Maryan; Mirmohamadi, Mahboubeh

2014-01-01

Nowadays, modern laboratories are faced with a huge volume of information. One of the goals of the Laboratory Information Management System (LIMS) is to assist in the management of the information generated in the laboratory. This study intends to evaluate the LIMS based on the standards of the American National Standard Institute (ANSI). This research is a descriptive-analytical study, which had been conducted in 2011, on the LIMSs in use, in the teaching and private hospitals in Isfahan. The data collecting instrument was a checklist, which was made by evaluating three groups of information components namely: 'System capabilities', 'work list functions,' and 'reporting' based on LIS8-A. Data were analyzed using the SPSS 20. Data were analyzed using (relative) frequency, percentage. To compare the data the following statistical tests were used: Leven test, t-test, and Analysis of Variance (ANOVA). The results of the study indicated that the LIMS had a low conformity (30%) with LIS8-A (P = 0.001), with no difference between teaching and private hospitals (P = 0.806). The ANOVA revealed that in terms of conformity with the LIS8-A standard, there was a significant difference between the systems produced by different vendors (P = 0.023). According to the results, a Kowsar system with more than %57 conformity in the three groups of information components had a better conformity to the standard, compared to the other systems. This study indicated that none of the LIMSs had a good conformity to the standard. It seems that system providers did not pay sufficient attention to many of the information components required by the standards when designing and developing their systems. It was suggested that standards from certified organizations and institutions be followed in the design and development process of health information systems.

Incidence of Propionibacterium acnes in initially culture-negative thioglycollate broths-a prospective cohort study at a Danish University Hospital.

PubMed

Kvich, L; Jensen, P Ø; Justesen, U S; Bjarnsholt, T

2016-11-01

The aim of this study was to prospectively investigate the incidence of Propionibacterium acnes in thioglycollate broths reported as culture-negative at the Department of Clinical Microbiology, Rigshospitalet, to evaluate whether 5 days of incubation was enough to find all relevant cases. Five hundred thioglycollate broths reported as culture-negative after 5 days were consecutively collected and incubated for at least a further 9 days (at least 14 days of incubation in total). Only tissue samples from sterile sites of the body (n = 298), bone tissue (n = 197) and foreign material (n = 5) were included in this study. Samples were divided into two groups: infected group and control group. This made it possible to compare findings between groups, thereby making it possible to estimate the level of true-positive findings and contamination. Samples from 296 participants were included in this study. After exclusion criteria were met, P. acnes was cultured from ten out of 151 patients (6.6%) in the infected group and from one out of 138 participants (0.7%) in the control group. This resulted in more findings of P. acnes in the infected group on day 14 than on day 5 (p 0.002). Furthermore, P. acnes was cultured more often from bone tissue and tissue surrounding foreign materials on day 14 than on day 5 (p 0.04). Clinical microbiology laboratories should consider incubating thioglycollate broths for at least 14 days to find all relevant cases of P. acnes, especially when it comes to bone tissue and tissue surrounding foreign materials. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Resuscitation of acid-injured Salmonella in enrichment broth, in apple juice and on the surfaces of fresh-cut cucumber and apple.

PubMed

Liao, C-H; Fett, W F

2005-01-01

To investigate the resuscitation of acid-injured Salmonella enterica in selected enrichment broths, in apple juice and on cut surfaces of apple and cucumber slices. Following exposure to 2.4% acetic acid for 7 min, S. enterica (serovars Mbandaka, Chester and Newport) cells were used to inoculate enrichment broths, phosphate-buffered saline (PBS), apple juice and fruit slices. Injured Salmonella cells resuscitated and regained the ability to form colonies on selective agar (Xylose-Lysine-Tergitol 4) if they were incubated in lactose broth (LB), universal pre-enrichment broth (UPB) or buffered peptone water (BPW), but not in tetrathionate broth, PBS or apple juice. The resuscitation occurred at a significantly (P > 0.05) faster rate in UPB than in LB or BPW. The resuscitation also occurred on the surfaces of fresh-cut cucumber at 20 degrees C, but not at 4 degrees C. Acid-injured Salmonella cells resuscitated in nonselective enrichment broths at different rates, but not in selective enrichment broth, apple juice, PBS or on fresh-cut apple. Pre-enrichment of food samples in UPB prior to selective enrichment is recommended. Injured Salmonella cells have the ability to resuscitate on fresh-cut surfaces of cucumber when stored at abusive temperatures.

Antibiotic Fermentation Broth Treatment by a pilot upflow anaerobic sludge bed reactor and kinetic modeling.

PubMed

Coskun, T; Kabuk, H A; Varinca, K B; Debik, E; Durak, I; Kavurt, C

2012-10-01

In this study, an upflow anaerobic sludge blanket (UASB) mesophilic reactor was used to remove antibiotic fermentation broth wastewater. The hydraulic retention time was held constant at 13.3 days. The volumetric organic loading value increased from 0.33 to 7.43 kg(COD)m(-3)d(-1) using antibiotic fermentation broth wastewater gradually diluted with various ratios of domestic wastewater. A COD removal efficiency of 95.7% was obtained with a maximum yield of 3,700 L d(-1) methane gas production. The results of the study were interpreted using the modified Stover-Kincannon, first-order, substrate mass balance and Van der Meer and Heertjes kinetic models. The obtained kinetic coefficients showed that antibiotic fermentation broth wastewater can be successfully treated using a UASB reactor while taking COD removal and methane production into account. Copyright © 2012 Elsevier Ltd. All rights reserved.

Standards, Regulation and Registration of Dental Laboratories. An Industry Update.

PubMed

Giovannone, Paul L

2015-01-01

State dental associations are showing increased interest in maintaining current standards and regulations affecting the dental laboratory industry as mandated by the Food and Drug Administration. The domestic dental laboratory industry is being significantly stressed by foreign competition, rapid technology development and unprecedented consolidation, which are changing the way that prosthetic devices and restorations are manufactured and delivered to dentists. Of paramount importance to the prescribing dentist is the accurate documentation of the source and materials being used in prostheses being delivered to patients.

College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

PubMed

Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

2015-04-01

The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

Sensomics-Based Molecularization of the Taste of Pot-au-Feu, a Traditional Meat/Vegetable Broth.

PubMed

Kranz, Maximilian; Viton, Florian; Smarrito-Menozzi, Candice; Hofmann, Thomas

2018-01-10

Targeted quantification of 49 basic taste-active molecules, followed by the calculation of dose-over-threshold (DoT) factors, and taste re-engineering experiments revealed minerals, nucleotides/nucleosides, amino acids, organic acids, and carbohydrates as the key compounds of Pot-au-Feu, a traditional broth preparation from beef cuts and vegetables. Moreover, the dipeptide carnosine was identified to be the key inducer for the white-meaty and thick-sour orosensation of the broth, next to anserine and 1-deoxy-d-fructosyl-N-β-alanyl-l-histidine, the latter of which has been identified for the first time by means of a sensory-guided fractionation. Sensory studies revealed the threshold concentration of carnosine in model broth to decrease by a factor of 5 upon nonenzymatic glycosylation to reach 4.4 mmol/L for its Amadori product 1-deoxy-d-fructosyl-N-β-alanyl-l-histidine.

Pre-treatment step with Leuconostoc mesenteroides or L. pseudomesenteroides strains removes furfural from Zymomonas mobilis ethanolic fermentation broth.

PubMed

Hunter, William J; Manter, Daniel K

2014-10-01

Furfural is an inhibitor of growth and ethanol production by Zymomonas mobilis. This study used a naturally occurring (not GMO) biological pre-treatment to reduce that amount of furfural in a model fermentation broth. Pre-treatment involved inoculating and incubating the fermentation broth with strains of Leuconostoc mesenteroides or Leuconostoc pseudomesenteroides. The Leuconostoc strains converted furfural to furfuryl alcohol without consuming large amounts of dextrose in the process. Coupling this pre-treatment to ethanolic fermentation reduced furfural in the broth and improved growth, dextrose uptake and ethanol formation. Pre-treatment permitted ethanol formation in the presence of 5.2 g L(-1) furfural, which was otherwise inhibitive. The pre-treatment and presence of the Leuconostoc strains in the fermentation broth did not interfere with Z. mobilis ethanolic fermentation or the amounts of ethanol produced. The method suggests a possible technique for reducing the effect that furfural has on the production of ethanol for use as a biofuel. Published by Elsevier Ltd.

ISO/IEC 17025 laboratory accreditation of NRC Acoustical Standards Program

NASA Astrophysics Data System (ADS)

Wong, George S. K.; Wu, Lixue; Hanes, Peter; Ohm, Won-Suk

2004-05-01

Experience gained during the external accreditation of the Acoustical Standards Program at the Institute for National Measurement Standards of the National Research Council is discussed. Some highlights include the preparation of documents for calibration procedures, control documents with attention to reducing future paper work and the need to maintain documentation or paper trails to satisfy the external assessors. General recommendations will be given for laboratories that are contemplating an external audit in accordance to the requirements of ISO/IEC 17025.

Naval Research Laboratory Industrial Chemical Analysis and Respiratory Filter Standards Development

DTIC Science & Technology

2017-09-29

Filter Standards Development September 29, 2017 Approved for public release; distribution is unlimited. Thomas E. suTTo Materials and Systems Branch...LIMITATION OF ABSTRACT Naval Research Laboratory Industrial Chemical Analysis and Respiratory Filter Standards Development Thomas E. Sutto Naval Research...approach, developed by NRL, is tested by examining the filter behavior against a number of chemicals to determine if the NRL approach resulted in the

Pilot microscreen separation of Sclerotium rolfsii biomass and broth. [Sclerotium rolfsii

DOE Office of Scientific and Technical Information (OSTI.GOV)

Griffith, W.L.; Compere, A.L.; Cravens, J.B.

1981-01-01

Field production of scleroglucan biopolymer for micellular flooding near an injection well could eliminate two major polymer production costs, alcohol precipitation of polymer broth and resuspension of dry polymer in water. The use of microscreening could decrease these and another major polymer production cost, that of diatomaceous earth filtration. Bench and pilot tests using Rexnord 1, 6, and 21-..mu..m screens indicate that they provide efficient removal of gross solids from Sclerotium rolfsii culture broth partially diluted to viscosities suitable for field injection. Pilot centrifuge tests indicate that the microscreen backwash could be concentrated to a solid content of 2 tomore » 3% as volatile suspended solids, suitable for animal feed or by-product use. Although polishing filtration is required to remove residual formation plugging constituents, substantial decreases in capital costs and operating energy appear attainable if microscreening is used. 3 figures, 3 tables.« less

Separation and purification of γ-aminobutyric acid from fermentation broth by flocculation and chromatographic methodologies.

PubMed

Gao, Qiang; Duan, Qiang; Wang, Depei; Zhang, Yunze; Zheng, Chunyang

2013-02-27

To date, the multifunctional γ-aminobutyric acid (GABA) is mainly produced by microbial fermentation in industry. The purpose of this study was to find an effective method for separation and purification of 31.2 g/L initial GABA from the fermentation broth of Enterococcus raffinosus TCCC11660. To remove the impurities from fermentation broth, flocculation pretreatment using chitosan and sodium alginate was first implemented to facilitate subsequent filtration. Ultrafiltration followed two discontinuous diafiltration steps to effectively remove proteins and macromolecular pigments, and the resulting permeate was further decolored by DA201-CII resin at a high decoloration ratio and GABA recovery. Subsequently, ion exchange chromatography (IEC) with Amberlite 200C resin and gradient elution were applied for GABA separation from glutamate and arginine. Finally, GABA crystals of 99.1% purity were prepared via warm ethanol precipitation twice. Overall, our results reveal that the successive process including flocculation, filtration, ultrafiltration, decoloration, IEC, and crystallization is promising for scale-up GABA extraction from fermentation broth.

Effect of Sucrose Stearate on the Sensory-Related Quality of the Broth and Porridge of Ready-To-Eat Ginseng Chicken Soup Samgyetang.

PubMed

Triyannanto, Endy; Lee, Keun Taik

2017-01-01

The objective of this study was to assess the sensory-related characteristics of the broth and porridge of ready-to-eat (RTE) ginseng chicken soup ( Samgyetang ) with sucrose stearate added at various concentrations (0.1%, 0.2%, and 0.3%) during storage at 25°C for 12 mon. Scores indicating the lightness and size of fat droplets in the broth increased during storage as the sucrose stearate concentration increased, while the clarity scores decreased until 9 mon and the taste scores decreased throughout the storage period ( p <0.05). The porridge lightness increased as the concentration of sucrose stearate increased after 6 mon ( p <0.05), while scores indicating the softness and vividness were higher for treated samples with sucrose stearate than for the control group after 3 mon, despite a lack of significant differences among treatment groups ( p >0.05). The taste scores were lower for treated porridge samples than for the control group ( p <0.05), even though no significant differences were observed among the treatment groups ( p >0.05). The addition of sucrose stearate to the RTE Samgyetang broth improved the lightness (CIE L *) value of the broth and various sensory palatability parameters, including the color and fat droplet size of the broth and the softness and vividness of the porridge, despite reductions in broth clarity and taste scores for the broth and porridge during storage.

Microfluidic cartridges for DNA purification and genotyping processed in standard laboratory instruments

NASA Astrophysics Data System (ADS)

Focke, Maximilian; Mark, Daniel; Stumpf, Fabian; Müller, Martina; Roth, Günter; Zengerle, Roland; von Stetten, Felix

2011-06-01

Two microfluidic cartridges intended for upgrading standard laboratory instruments with automated liquid handling capability by use of centrifugal forces are presented. The first microfluidic cartridge enables purification of DNA from human whole blood and is operated in a standard laboratory centrifuge. The second microfluidic catridge enables genotyping of pathogens by geometrically multiplexed real-time PCR. It is operated in a slightly modified off-the-shelf thermal cycler. Both solutions aim at smart and cost-efficient ways to automate work flows in laboratories. The DNA purification cartridge automates all liquid handling steps starting from a lysed blood sample to PCR ready DNA. The cartridge contains two manually crushable glass ampoules with liquid reagents. The DNA yield extracted from a 32 μl blood sample is 192 +/- 30 ng which corresponds to 53 +/- 8% of a reference extraction. The genotyping cartridge is applied to analyse isolates of the multi-resistant Staphyloccus aureus (MRSA) by real-time PCR. The wells contain pre-stored dry reagents such as primers and probes. Evaluation of the system with 44 genotyping assays showed a 100% specificity and agreement with the reference assays in standard tubes. The lower limit of detection was well below 10 copies of DNA per reaction.

[Statistical approach to evaluate the occurrence of out-of acceptable ranges and accuracy for antimicrobial susceptibility tests in inter-laboratory quality control program].

PubMed

Ueno, Tamio; Matuda, Junichi; Yamane, Nobuhisa

2013-03-01

To evaluate the occurrence of out-of acceptable ranges and accuracy of antimicrobial susceptibility tests, we applied a new statistical tool to the Inter-Laboratory Quality Control Program established by the Kyushu Quality Control Research Group. First, we defined acceptable ranges of minimum inhibitory concentration (MIC) for broth microdilution tests and inhibitory zone diameter for disk diffusion tests on the basis of Clinical and Laboratory Standards Institute (CLSI) M100-S21. In the analysis, more than two out-of acceptable range results in the 20 tests were considered as not allowable according to the CLSI document. Of the 90 participating laboratories, 46 (51%) experienced one or more occurrences of out-of acceptable range results. Then, a binomial test was applied to each participating laboratory. The results indicated that the occurrences of out-of acceptable range results in the 11 laboratories were significantly higher when compared to the CLSI recommendation (allowable rate < or = 0.05). The standard deviation indices(SDI) were calculated by using reported results, mean and standard deviation values for the respective antimicrobial agents tested. In the evaluation of accuracy, mean value from each laboratory was statistically compared with zero using a Student's t-test. The results revealed that 5 of the 11 above laboratories reported erroneous test results that systematically drifted to the side of resistance. In conclusion, our statistical approach has enabled us to detect significantly higher occurrences and source of interpretive errors in antimicrobial susceptibility tests; therefore, this approach can provide us with additional information that can improve the accuracy of the test results in clinical microbiology laboratories.

Significant decrease of broth viscosity and glucose consumption in erythromycin fermentation by dynamic regulation of ammonium sulfate and phosphate.

PubMed

Chen, Yong; Wang, Zejian; Chu, Ju; Zhuang, Yingping; Zhang, Siliang; Yu, Xiaoguang

2013-04-01

In this study, the effects of nitrogen sources on broth viscosity and glucose consumption in erythromycin fermentation were investigated. By controlling ammonium sulfate concentration, broth viscosity and glucose consumption were decreased by 18.2% and 61.6%, respectively, whereas erythromycin biosynthesis was little affected. Furthermore, erythromycin A production was increased by 8.7% still with characteristics of low broth viscosity and glucose consumption through the rational regulations of phosphate salt, soybean meal and ammonium sulfate. It was found that ammonium sulfate could effectively control proteinase activity, which was correlated with the utilization of soybean meal as well as cell growth. The pollets formation contributed much to the decrease of broth viscosity. The accumulation of extracellular propionate and succinate under the new regulation strategy indicated that higher propanol consumption might increase the concentration of methylmalonyl-CoA and propionyl-CoA and thus could increase the flux leading to erythromycin A. Copyright © 2013 Elsevier Ltd. All rights reserved.

Preliminary Evaluation of the Control of Microbial Fouling by Laboratory and Pilot-Scale Air-Stripping Columns

DTIC Science & Technology

1985-03-01

used to remove trichloroethylene (TCE) from contaminated well water. 7 MATERIALS Chemicals: Trichloroethylene (Aldrich chemical, Milwaukee, WI), sodium ...Cleveland, OH), sodium hydrcxide (J.T. Baker, Phillipsburg, NJ), potassium dichloroisocyanurate (Dorex Inc., Frankfort, IL), potassium iodide starch...NJ). Media and Reagents: Plate count agar (Difco Laboratories, Detroit, MI), lauryl tryptose broth (Difco Laboratories, Detroit, MI), motility medium

Effect of Sucrose Stearate on the Sensory-Related Quality of the Broth and Porridge of Ready-To-Eat Ginseng Chicken Soup Samgyetang

PubMed Central

Triyannanto, Endy

2017-01-01

The objective of this study was to assess the sensory-related characteristics of the broth and porridge of ready-to-eat (RTE) ginseng chicken soup (Samgyetang) with sucrose stearate added at various concentrations (0.1%, 0.2%, and 0.3%) during storage at 25°C for 12 mon. Scores indicating the lightness and size of fat droplets in the broth increased during storage as the sucrose stearate concentration increased, while the clarity scores decreased until 9 mon and the taste scores decreased throughout the storage period (p<0.05). The porridge lightness increased as the concentration of sucrose stearate increased after 6 mon (p<0.05), while scores indicating the softness and vividness were higher for treated samples with sucrose stearate than for the control group after 3 mon, despite a lack of significant differences among treatment groups (p >0.05). The taste scores were lower for treated porridge samples than for the control group (p<0.05), even though no significant differences were observed among the treatment groups (p >0.05). The addition of sucrose stearate to the RTE Samgyetang broth improved the lightness (CIE L*) value of the broth and various sensory palatability parameters, including the color and fat droplet size of the broth and the softness and vividness of the porridge, despite reductions in broth clarity and taste scores for the broth and porridge during storage. PMID:29725207

Development of a Fan-Filter Unit Test Standard, LaboratoryValidations, and its Applications across Industries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xu, Tengfang

2006-10-20

Lawrence Berkeley National Laboratory (LBNL) is now finalizing the Phase 2 Research and Demonstration Project on characterizing 2-foot x 4-foot (61-cm x 122-cm) fan-filter units in the market using the first-ever standard laboratory test method developed at LBNL.[1][2][3] Fan-filter units deliver re-circulated air and provide particle filtration control for clean environments. Much of the energy in cleanrooms (and minienvironments) is consumed by 2-foot x 4-foot (61-cm x 122-cm) or 4-foot x 4-foot (122-cm x 122-cm) fan-filter units that are typically located in the ceiling (25-100% coverage) of cleanroom controlled environments. Thanks to funding support by the California Energy Commission's Industrialmore » Program of the Public Interest Energy Research (PIER) Program, and significant participation from manufacturers and users of fan-filter units from around the world, LBNL has developed and performed a series of standard laboratory tests and reporting on a variety of 2-foot x 4-foot (61-cm x 122-cm) fan-filter units (FFUs). Standard laboratory testing reports have been completed and reported back to anonymous individual participants in this project. To date, such reports on standard testing of FFU performance have provided rigorous and useful data for suppliers and end users to better understand, and more importantly, to quantitatively characterize performance of FFU products under a variety of operating conditions.[1] In the course of the project, the standard laboratory method previously developed at LBNL has been under continuous evaluation and update.[2][3] Based upon the updated standard, it becomes feasible for users and suppliers to characterize and evaluate energy performance of FFUs in a consistent way.« less

Chemical constituents of the fermentation broth of the marine-derived fungus Penicillium roqueforti.

PubMed

Mioso, Roberto; Marante, Francisco Javier Toledo; Laguna, Irma Herrera Bravo de

2015-01-01

The filamentous fungus Penicillium roqueforti is a well-known multifunctional cell factory of high added-value biomolecules. The objective of this work was to carry out a detailed analysis of the metabolites present in the culture broth of a new marine-derived Penicillium roqueforti strain isolated in the Canary Islands, Spain. The fungal biomass production was carried out in liquid-state fermentation, and after 10-12 days of incubation at 22-25°C, the supernatant mycelia was separated by filtration, and the culture broth (12l) was stored in a refrigerator at 4°C for a subsequent liquid-liquid extraction with dichloromethane (3×), in accordance with the modified Kupchan method. The volatile and semi-volatile organic compounds were separated by chromatography and analyzed using GC-MS and NMR spectroscopy analyses. Several volatile organic compounds involved in the fatty acid pathway were identified: a terpenoid, a cyclic dipeptide, phthalates, and an alkyl adipate. In addition, three categories of non-volatile compounds (alkanes, fatty acids and 1-alkanols) were identified by spectroscopy. The results show that the fermented broth of this fungal strain has no mycotoxins under the culture conditions applied. It is hoped that this chemo-specific information will offer critical input for improving the biotechnological applications of this filamentous fungus. Copyright © 2013 Revista Iberoamericana de Micología. Published by Elsevier Espana. All rights reserved.

Integrating standard operating procedures and industry notebook standards to evaluate students in laboratory courses.

PubMed

Wallert, Mark A; Provost, Joseph J

2014-01-01

To enhance the preparedness of graduates from the Biochemistry and Biotechnology (BCBT) Major at Minnesota State University Moorhead for employment in the bioscience industry we have developed a new Industry certificate program. The BCBT Industry Certificate was developed to address specific skill sets that local, regional, and national industry experts identified as lacking in new B.S. and B.A. biochemistry graduates. The industry certificate addresses concerns related to working in a regulated industry such as Good Laboratory Practices, Good Manufacturing Practices, and working in a Quality System. In this article we specifically describe how we developed a validation course that uses Standard Operating Procedures to describe grading policy and laboratory notebook requirements in an effort to better prepare students to transition into industry careers. © 2013 by The International Union of Biochemistry and Molecular Biology.

Hydrogen Field Test Standard: Laboratory and Field Performance

PubMed Central

Pope, Jodie G.; Wright, John D.

2015-01-01

The National Institute of Standards and Technology (NIST) developed a prototype field test standard (FTS) that incorporates three test methods that could be used by state weights and measures inspectors to periodically verify the accuracy of retail hydrogen dispensers, much as gasoline dispensers are tested today. The three field test methods are: 1) gravimetric, 2) Pressure, Volume, Temperature (PVT), and 3) master meter. The FTS was tested in NIST's Transient Flow Facility with helium gas and in the field at a hydrogen dispenser location. All three methods agree within 0.57 % and 1.53 % for all test drafts of helium gas in the laboratory setting and of hydrogen gas in the field, respectively. The time required to perform six test drafts is similar for all three methods, ranging from 6 h for the gravimetric and master meter methods to 8 h for the PVT method. The laboratory tests show that 1) it is critical to wait for thermal equilibrium to achieve density measurements in the FTS that meet the desired uncertainty requirements for the PVT and master meter methods; in general, we found a wait time of 20 minutes introduces errors < 0.1 % and < 0.04 % in the PVT and master meter methods, respectively and 2) buoyancy corrections are important for the lowest uncertainty gravimetric measurements. The field tests show that sensor drift can become a largest component of uncertainty that is not present in the laboratory setting. The scale was calibrated after it was set up at the field location. Checks of the calibration throughout testing showed drift of 0.031 %. Calibration of the master meter and the pressure sensors prior to travel to the field location and upon return showed significant drifts in their calibrations; 0.14 % and up to 1.7 %, respectively. This highlights the need for better sensor selection and/or more robust sensor testing prior to putting into field service. All three test methods are capable of being successfully performed in the field and give

Validation of Radiometric Standards for the Laboratory Calibration of Reflected-Solar Earth Observing Satellite Instruments

NASA Technical Reports Server (NTRS)

Butler, James J.; Johnson, B. Carol; Rice, Joseph P.; Brown, Steven W.; Barnes, Robert A.

2007-01-01

Historically, the traceability of the laboratory calibration of Earth-observing satellite instruments to a primary radiometric reference scale (SI units) is the responsibility of each instrument builder. For the NASA Earth Observing System (EOS), a program has been developed using laboratory transfer radiometers, each with its own traceability to the primary radiance scale of a national metrology laboratory, to independently validate the radiances assigned to the laboratory sources of the instrument builders. The EOS Project Science Office also developed a validation program for the measurement of onboard diffuse reflecting plaques, which are also used as radiometric standards for Earth-observing satellite instruments. Summarized results of these validation campaigns, with an emphasis on the current state-of-the-art uncertainties in laboratory radiometric standards, will be presented. Future mission uncertainty requirements, and possible enhancements to the EOS validation program to ensure that those uncertainties can be met, will be presented.

Expression of food-grade phytase in Lactococcus lactis from optimized conditions in milk broth.

PubMed

Miao, Yuzhi; Xu, Hui; Fei, Baojin; Qiao, Dairong; Cao, Yi

2013-07-01

The major objective of this study was to engineer lactic acid bacteria to produce the enzyme phytase from a gene native to Bacillus subtilis GYPB04. The phytase gene (phyC) of B. subtilis GYPB04 was cloned into the plasmid pMG36e for expression in Lactococcus lactis. The enzyme activity in L. lactis cultured in GM17 broth was 20.25 U/mL at 36°C. The expressed phytase was characterized as active in a pH range of 2.0-9.0 at a temperature range of 20-80°C, with an optimum pH of 5.5-6.5 and temperature of 60°C. When cultured in food-grade milk broth, the transformed L. lactis grew to an OD(600 nm) value of 1.05 and had a phytase yield of 13.58 U/mL. In same broth under optimized conditions for cell growth and phytase production, the transformant reached an OD(600 nm) value of 1.68 and a phytase yield of 42.12 U/mL, representing approximately 1.6-fold and 3.1-fold increases, respectively, compared to growth in natural milk broth. Fermentation was scaled to 5 L under optimized conditions, and product analysis revealed a final OD(600 nm) value of 1.89 and an extracellular enzyme activity of 24.23 U/mL. The results of this study may be used in the dairy fermentation industry for the development of functional, healthy yogurts and other fermented dairy foods that provide both active phytase and viable probiotics to the consumer. Copyright © 2013 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

Comparison of Disk Diffusion, VITEK 2, and Broth Microdilution Antimicrobial Susceptibility Test Results for Unusual Species of Enterobacteriaceae▿

PubMed Central

Stone, Nimalie D.; O'Hara, Caroline M.; Williams, Portia P.; McGowan, John E.; Tenover, Fred C.

2007-01-01

We compared the antimicrobial susceptibility testing results generated by disk diffusion and the VITEK 2 automated system with the results of the Clinical and Laboratory Standards Institute (CLSI) broth microdilution (BMD) reference method for 61 isolates of unusual species of Enterobacteriaceae. The isolates represented 15 genera and 26 different species, including Buttiauxella, Cedecea, Kluyvera, Leminorella, and Yokenella. Antimicrobial agents included aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, and trimethoprim-sulfamethoxazole. CLSI interpretative criteria for Enterobacteriaceae were used. Of the 12 drugs tested by BMD and disk diffusion, 10 showed >95% categorical agreement (CA). CA was lower for ampicillin (80.3%) and cefazolin (77.0%). There were 3 very major errors (all with cefazolin), 1 major error (also with cefazolin), and 26 minor errors. Of the 40 isolates (representing 12 species) that could be identified with the VITEK 2 database, 36 were identified correctly to species level, 1 was identified to genus level only, and 3 were reported as unidentified. VITEK 2 generated MIC results for 42 (68.8%) of 61 isolates, but categorical interpretations (susceptible, intermediate, and resistant) were provided for only 22. For the 17 drugs tested by both BMD and VITEK 2, essential agreement ranged from 80.9 to 100% and CA ranged from 68.2% (ampicillin) to 100%; thirteen drugs exhibited 100% CA. In summary, disk diffusion provides a reliable alternative to BMD for testing of unusual Enterobacteriaceae, some of which cannot be tested, or produce incorrect results, by automated methods. PMID:17135429

Present status and perspective of laboratory hematology in Japan: On the standardization of blood cell morphology including myelodysplasia: On behalf of the Japanese Society for Laboratory Hematology.

PubMed

Tohyama, K

2018-05-01

The Japanese Society for Laboratory Hematology (JSLH) was launched in 2000 and has been developed by a mutual collaboration of hematologists, medical technologists, and the companies involved in hematological laboratory testing. The aim of JSLH is the progress and development of laboratory hematology by academic conferences, periodic publication of academic journal, training and education (in the meeting, the journal, or the website), promotion of the standardization of laboratory hematology, and certification of the laboratory hematology specialists. Among 3 specialized committees organized for the standardization of laboratory hematology, the standardization committee on blood cell morphology has been dealing with the various projects on peripheral/bone marrow blood cells and normal/abnormal morphology. Another independent organization, the Japanese National Research Group on idiopathic bone marrow failure syndromes (BMF), has raised the importance of the dysplasia of myelodysplastic syndromes (MDS) and has been conducting the prospective registration, central review, and follow-up study of MDS. This group recently proposed the grading system for diagnostic accuracy of MDS, and the detailed procedure of morphological diagnosis of MDS is presented in the specialized color atlas with typical photographs of various dysplasia. JSLH has also approved the grading system for diagnostic accuracy of MDS and adopted this standardized diagnostic system to the educational item for certification of the laboratory hematology specialists, aiming at a nationwidely expanding morphological evaluation of myelodysplasia. Further and significant progress in the standardization of blood cell morphology will be expected in Japan through the activity of JSLH. © 2018 John Wiley & Sons Ltd.

Updated standards and processes for accreditation of echocardiographic laboratories from The European Association of Cardiovascular Imaging.

PubMed

Popescu, Bogdan A; Stefanidis, Alexandros; Nihoyannopoulos, Petros; Fox, Kevin F; Ray, Simon; Cardim, Nuno; Rigo, Fausto; Badano, Luigi P; Fraser, Alan G; Pinto, Fausto; Zamorano, Jose Luis; Habib, Gilbert; Maurer, Gerald; Lancellotti, Patrizio; Andrade, Maria Joao; Donal, Erwan; Edvardsen, Thor; Varga, Albert

2014-07-01

Standards for echocardiographic laboratories were proposed by the European Association of Echocardiography (now the European Association of Cardiovascular Imaging) 7 years ago in order to raise standards of practice and improve the quality of care. Criteria and requirements were published at that time for transthoracic, transoesophageal, and stress echocardiography. This paper reassesses and updates the quality standards to take account of experience and the technical developments of modern echocardiographic practice. It also discusses quality control, the incentives for laboratories to apply for accreditation, the reaccreditation criteria, and the current status and future prospects of the laboratory accreditation process. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

76 FR 38550 - Technical Standard DOE-STD-1095-2011, Department of Energy Laboratory Accreditation for External...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... Laboratory Accreditation for External Dosimetry AGENCY: Office of Health, Safety and Security, Department of... Department) is issuing Technical Standard DOE-STD-1095-2011, Department of Energy Laboratory Accreditation... part, to determine whether to accredit dosimetry programs in accordance with the DOE Laboratory...

New antioxidants from the culture broth of Hericium coralloides.

PubMed

Kim, Ji-Yul; Woo, E-Eum; Lee, In-Kyoung; Yun, Bong-Sik

2018-05-17

In our effort to find antioxidants from the higher fungi, we isolated three new compounds (1-3) with a known compound, spirobenzofuran (4), from the culture broth of Hericium coralloides. Bioassay-guided fractionation led to the isolation of these compounds, and we determined the chemical structures through spectroscopic methods. These compounds exhibited antioxidant activity in the range of IC 50 values of 29-66 μM in the 2,2'-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS) radical-scavenging assay.

Submerged-Culture Mycelia and Broth of the Maitake Medicinal Mushroom Grifola frondosa (Higher Basidiomycetes) Alleviate Type 2 Diabetes-Induced Alterations in Immunocytic Function.

PubMed

Chen, Ya-Hui; Lee, Chien-Hsing; Hsu, Tai-Hao; Lo, Hui-Chen

2015-01-01

Type 2 Diabetes mellitus (T2DM), a disease with impaired glucose, protein and lipid metabolism, low-grade chronic inflammation, and immune dysfunction, is a global public health crisis. We previously demonstrated that Grifola frondosa has bioactivities in improving glycemic responses in diabetic rats. Herein, we investigated the immunomodulatory effects of the submerged-culture mycelia and broth of G. frondosa on the peripheral blood cells (PBL) and splenocytes. Male Wistar rats were administered with saline (normal rats) or streptozotocin plus nicotinamide (T2DM rats) and were intragastrically administered with placebo, fermented mycelia, broth, or mycelia plus broth (1 g kg-1 day-1) for two weeks. In normal rats, ingestion of mycelia significantly decreased monocytes and ingestion of mycelia and broth significantly decreased the productions of interferon (IFN)-γ and interleukin (IL)-4 from the PBL and splenocytes. In T2DM rats, ingestion of mycelia, broth, and mycelia plus broth significantly alleviated the increases in 2 h postprandial blood glucose and the productions of IFN-γ from the T-leukocytes, IL-4, and IL-6 from the monocytes and IL-4 from the T-splenocytes, as well as significantly improved the productions of tumor-necrosis factor-α from the macrophages. In conclusion, submerged-culture mycelia and broth of G. frondosa may decrease cell-medicated immunity in normal rats and improve hyperglycemia and diabetes-induced alterations in cell-medicated and innate immunities in T2DM rats.

Improving consistency in large laboratory courses: a design for a standardized practical exam.

PubMed

Chen, Xinnian; Graesser, Donnasue; Sah, Megha

2015-06-01

Laboratory courses serve as important gateways to science, technology, engineering, and mathematics education. One of the challenges in assessing laboratory learning is to conduct meaningful and standardized practical exams, especially for large multisection laboratory courses. Laboratory practical exams in life sciences courses are frequently administered by asking students to move from station to station to answer questions, apply knowledge gained during laboratory experiments, interpret data, and identify various tissues and organs using various microscopic and gross specimens. This approach puts a stringent time limit on all questions regardless of the level of difficulty and also invariably increases the potential risk of cheating. To avoid potential cheating in laboratory courses with multiple sections, the setup for practical exams is often changed in some way between sections. In laboratory courses with multiple instructors or teaching assistants, practical exams may be handled inconsistently among different laboratory sections, due to differences in background knowledge, perceptions of the laboratory goals, or prior teaching experience. In this article, we describe a design for a laboratory practical exam that aims to align the assessment questions with well-defined laboratory learning objectives and improve the consistency among all laboratory sections. Copyright © 2015 The American Physiological Society.

Differences in Anticipatory Behaviour between Rats (Rattus norvegicus) Housed in Standard versus Semi-Naturalistic Laboratory Environments.

PubMed

Makowska, I Joanna; Weary, Daniel M

2016-01-01

Laboratory rats are usually kept in relatively small cages, but research has shown that they prefer larger and more complex environments. The physiological, neurological and health effects of standard laboratory housing are well established, but fewer studies have addressed the sustained emotional impact of a standard cage environment. One method of assessing affective states in animals is to look at the animals' anticipatory behaviour between the presentation of a cue signalling the arrival of a reward and the arrival of that reward. The primary aim of this study was to use anticipatory behaviour to assess the affective state experienced by female rats a) reared and housed long-term in a standard laboratory cage versus a semi-naturalistic environment, and b) before and after treatment with an antidepressant or an anxiolytic. A secondary aim was to add to the literature on anticipatory behaviour by describing and comparing the frequency and duration of individual elements of anticipatory behaviour displayed by rats reared in these two systems. In all experiments, total behavioural frequency was higher in standard-housed rats compared to rats from the semi-naturalistic condition, suggesting that standard-housed rats were more sensitive to rewards and experiencing poorer welfare than rats reared in the semi-naturalistic environment. What rats did in anticipation of the reward also differed between housing treatments, with standard-housed rats mostly rearing and rats from the semi-naturalistic condition mostly sitting facing the direction of the upcoming treat. Drug interventions had no effect on the quantity or form of anticipatory behaviour, suggesting that the poorer welfare experienced by standard-housed rats was not analogous to depression or anxiety, or alternatively that the drug interventions were ineffective. This study adds to mounting evidence that standard laboratory housing for rats compromises rat welfare, and provides further scientific support for

Creating Cost-Effective DNA Size Standards for Use in Teaching and Research Laboratories

ERIC Educational Resources Information Center

Shultz, Jeff

2011-01-01

I have devised a method with which a molecular size standard can be readily manufactured using Lambda DNA and PCR. This method allows the production of specific sized DNA fragments and is easily performed in a standard molecular biology laboratory. The material required to create these markers can also be used to provide a highly robust and…

Use of blood-free enrichment broth in the development of a rapid protocol to detect Campylobacter in twenty-five grams of chicken meat.

PubMed

Hayashi, Masahiro; Kubota-Hayashi, Sayoko; Natori, Tatsuya; Mizuno, Takuya; Miyata, Machiko; Yoshida, Shigeru; Zhang, Jiwei; Kawamoto, Keiko; Ohkusu, Kiyofumi; Makino, Souichi; Ezaki, Takayuki

2013-04-15

A Food Pathogen Enrichment (FPE) broth, which supports the growth of Campylobacter without lysed blood and CO2, was developed. The FPE broth supports the growth of Campylobacter to the same degree as Bolton and Preston broths. Using the FPE broth, we developed a novel rapid protocol to detect small numbers of Campylobacter in 25g of food. The sensitivity of FPE enrichment and PCR to detect Campylobacter spp. from spiked chicken meat was determined. The detection sensitivities for non-stressed C. jejuni and C. coli from fresh meat ranged from 5.8 to 1.1×10(1)CFU per 25g of chicken meat, and those for freeze-stressed C. jejuni and C. coli from frozen meat ranged from 9.9×10(1) to 2.0×10(2)CFU. The FPE broth enrichment culture (24h) of chicken meat, followed by PCR, resulted in a significantly higher detection score (80% positive) than conventional Bolton enrichment and subsequent colony isolation using mCCDA agar plates (18% positive). Differences between our new protocol and the Bolton enrichment method were due to the overgrowth of many resistant bacteria, especially extended-spectrum beta-lactamase-producing bacteria in the Bolton enrichment broth. Copyright © 2013 Elsevier B.V. All rights reserved.

Adaptation of the Sensititre broth microdilution technique to antimicrobial susceptibility testing of Mycoplasma hyopneumoniae.

PubMed

Tanner, A C; Erickson, B Z; Ross, R F

1993-09-01

A broth microdilution technique is described for determining the antimicrobial susceptibility of Mycoplasma hyopneumoniae, using commercially prepared Sensititre plates. Twenty-five field isolates and two reference strains (J & 232), were tested against seven antimicrobials. Field isolates were tested in duplicate and reference strains, four times to estimate reproducibility. Ninety-seven percent of the duplicate MIC results for the field isolates were in agreement, or within one log2 dilution. Similar results were obtained with the reference strains. The isolates were susceptible to lincomycin-spectinomycin, tylosin and oxytetracycline or resistant to amoxycillin, apramycin and erythromycin. Susceptibility to furaltadone varied. This method retains the accuracy and reproducibility of broth MIC determinations, while avoiding the lengthy preparation of antimicrobial dilutions normally associated with more traditional methods.

75 FR 39023 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-07

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 27348 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 9229 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 5088 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 154 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 32950 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-10

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 55795 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

New phenyl-ethanediols from the culture broth of Boletus edulis.

PubMed

Yang, Wan-Qiu; Qin, Xiang-Dong; Shao, Hong-Jun; Fang, Li-Zhen; Wang, Fei; Ding, Zhi-Hui; Dong, Ze-Jun; Liu, Ji-Kai

2007-04-01

A new phenyl-ethanediol, (1S)-(4-acetylphenyl)-1, 2-ethanediol (1), and a new natural product, (1S)-(3-ethenylphenyl)-1, 2-ethanediol (2), were isolated from the culture broth of the basidiomycete Boletus edulis together with three related known compounds, 1-(4-ethylphenyl)-1, 2-ethanediol (3), 1-(3-ethylphenyl)-1, 2-ethanediol (4) and 1-(3-formylphenyl)-ethanone (5). Their structures were elucidated by spectroscopic methods including extensive 2D-NMR techniques.

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

75 FR 45128 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the..., ``Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

76 FR 25376 - Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... describes: Standard operating procedures for using hazardous chemicals; hazard-control techniques; equipment...] Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of Management... collection requirements specified in the Standard on Occupational Exposure to Hazardous Chemicals in...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Standard hourly fee rate for laboratory testing, analysis, and other services. 91.37 Section 91.37 Agriculture Regulations of the Department of Agriculture... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and...

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE: CONSTITUTION, BYLAWS AND STANDARDS; APPROVED JUNE 2000

EPA Science Inventory

As Director of the Environmental Protection Agency's National Environmental
Laboratory Accreditation Program (NELAP), I offer my sincere appreciation to the many individuals who worked on the 2000 revision of the NELAC standards. I would like to give special recognition to th...

Clinical and economic evaluation of BBL CHROMagar Salmonella (CHROMSal) versus subculture after selenite broth enrichment to CHROMSal and Hektoen enteric agars to detect enteric Salmonella in a large regional microbiology laboratory.

PubMed

Church, Deirdre L; Emshey, Diana; Lloyd, Tracie; Pitout, Johann

2010-09-01

Stool culture for enteric pathogens is one of the most labor-intensive clinical microbiology procedures. Direct plating of stool to BBL CHROMagar Salmonella (CHROMSal) (BD Diagnostics, Sparks, MD) versus subculture after selenite broth enrichment (Sel) to CHROMSal (Sel-CHROMSal) and Hektoen enteric agar (Sel-Hek) (PML Microbiologicals, Eugene, OR) to detect Salmonella were compared. The number of colony picks and biochemical/serotyping tests per plate was recorded. A cost comparison was done. Fifty-one of 2999 (1.7%) stools yielded Salmonella sp., and 80% of isolates grew on CHROMSal by 24 h. CHROMSal demonstrated much less false-positive growth compared to Sel-Hek (P < 0.0001), which reduced biochemical and serotyping tests by 85% and 20%, respectively. Sel-CHROMSal and CHROMSal versus Sel-Hek improved enteric Salmonella detection when compared to a true positive "gold standard" (i.e., recovery by any culture method) with a sensitivity, specificity, positive predictive value, and negative predictive value of 100% and 94.12%, 100% and 99.97%, 100% and 97.96%, and 100% and 99.90%, respectively. CHROMSal use would result in substantial cost and labor savings.

Standard Specification for Language Laboratory.

ERIC Educational Resources Information Center

North Carolina State Dept. of Administration, Raleigh.

This specification covers the components of electronic and electromechanical equipment, nonelectronic materials for the teacher-student positions, and other items of a miscellaneous nature to provide for a complete and workable language laboratory facility. Language laboratory facilities covered by this specification are of two types: (1)…

Attachment of Escherichia coli O157:H7 grown in tryptic soy broth and nutrient broth to apple and lettuce surfaces as related to cell hydrophobicity, surface charge, and capsule production.

PubMed

Hassan, A N; Frank, J F

2004-10-01

This study investigated the effect of growth in tryptic soy broth (TSB) and nutrient broth (NB) on the ability Escherichia coli O157:H7 to attach to lettuce and apple surfaces. In addition, cell surface hydrophobicity, charge and capsule production were determined on cells grown in these media. Cells grown in NB attached less to lettuce and apple surfaces than did those grown in TSB. TSB, but not NB, supported capsule production by E. coli O157:H7. Cells grown in TSB were more hydrophilic than those grown in NB. No difference was found in the electrokinetic properties of cells grown in these media. Electrostatic and hydrophobic interactions and surface proteins did not appear to play an important role in the attachment of E. coli O157:H7 to these surfaces. Of the factors studied, only capsule production was associated with attachment ability. Copyright 2003 Elsevier B.V.

Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

PubMed Central

Shryock, T R; White, D W; Werner, C S; Staples, J M

1995-01-01

Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

78 FR 63999 - Notice of Vitamin D Standardization Program (VDSP) Symposium: Tools To Improve Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Vitamin D Standardization Program (VDSP) Symposium: Tools To Improve Laboratory Measurement SUMMARY: The National Institutes of Health, Office of Dietary Supplements (ODS), and the National Institute of Standards and...

Thermal inactivation and sublethal injury kinetics of Salmonella enterica and Listeria monocytogenes in broth versus agar surface.

PubMed

Wang, Xiang; Devlieghere, Frank; Geeraerd, Annemie; Uyttendaele, Mieke

2017-02-21

The objective of the present study was to compare the thermal inactivation and sublethal injury kinetics of Salmonella enterica and Listeria monocytogenes in broth (suspended cells) and on solid surface (agar-seeded cells). A 3-strain cocktail of S. enterica or L. monocytogenes inoculated in broth or on agar was subjected to heating in a water bath at various set temperatures (55.0, 57.5 and 60.0°C for S. enterica and 60.0, 62.5 and 65°C for L. monocytogenes). The occurrence of sublethally injured cells was determined by comparing enumerations on nonselective (TSAYE) and selective (XLD or ALOA) media. Results showed that the inactivation curves obtained from selective media were log-linear, and significant shoulders (p<0.05) were observed on some of the inactivation curves from TSAYE media. The D-values derived from the total population were higher than those from the uninjured cells. Generally, cells on agar surface exhibited higher heat resistance than those in broth. For S. enterica, cell injury increased with the exposure time, no difference was observed when treated at temperatures from 55.0 to 60.0°C, while for L. monocytogenes, cell injury increased significantly with heating time and treatment temperature (from 60.0 to 65°C). Moreover, the degree of sublethal injury affected by thermal treatment in broth or on agar surface depended upon the target microorganism. Higher proportions of injured S. enterica cells were observed for treatment in broth than on agar surface, while the opposite was found for L. monocytogenes. The provided information may be used to assess the efficacy of thermal treatment processes on surfaces for inactivation of S. enterica and L. monocytogenes, and it provides insight into the sublethally injured survival state of S. enterica and L. monocytogenes treated in liquid or on solid food. Copyright © 2016 Elsevier B.V. All rights reserved.

Recovery of butanol from Clostridium beijerinckii P260 fermentation broth by supercritical CO

USDA-ARS?s Scientific Manuscript database

Butanol is a superior biofuel to ethanol because of its blend properties and higher energy density. However, its recovery by distillation from the fermentation broth is energy intensive. For this reason, we studied butanol recovery by supercritical CO2 extraction from simulated and actual fermentati...

In Vitro Antibiotic Susceptibilities of Burkholderia mallei (Causative Agent of Glanders) Determined by Broth Microdilution and E-Test

PubMed Central

Heine, Henry S.; England, Marilyn J.; Waag, David M.; Byrne, W. Russell

2001-01-01

In vitro susceptibilities to 28 antibiotics were determined for 11 strains of Burkholderia mallei by the broth microdilution method. The B. mallei strains demonstrated susceptibility to aminoglycosides, macrolides, quinolones, doxycycline, piperacillin, ceftazidime, and imipenem. For comparison and evaluation, 17 antibiotic susceptibilities were also determined by the E-test. E-test values were always lower than the broth dilution values. Establishing and comparing antibiotic susceptibilities of specific B. mallei strains will provide reference information for assessing new antibiotic agents. PMID:11408233

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE; CONSTITUTION, BYLAWS AND STANDARDS: APPROVED MAY 25, 2001

EPA Science Inventory

The principles and operating procedures for the National Environmental Laboratory Accreditation Conference (NELAC) are contained in the NELAC Constitution and Bylaws. The major portion of this document (standards) contains detailed requirements for accrediting environmental labo...

Ion-exclusion chromatography determination of organic acid in uridine 5'-monophosphate fermentation broth.

PubMed

Niu, Huanqing; Chen, Yong; Xie, Jingjing; Chen, Xiaochun; Bai, Jianxin; Wu, Jinglan; Liu, Dong; Ying, Hanjie

2012-09-01

Simultaneous determination of organic acids using ion-exclusion liquid chromatography and ultraviolet detection is described. The chromatographic conditions are optimized when an Aminex HPX-87H column (300 × 7.8 mm) is employed, with a solution of 3 mmol/L sulfuric acid as eluent, a flow rate of 0.4 mL/min and a column temperature of 60°C. Eight organic acids (including orotic acid, α-ketoglutaric acid, citric acid, pyruvic acid, malic acid, succinic acid, lactic acid and acetic acid) and one nucleotide are successfully quantified. The calibration curves for these analytes are linear, with correlation coefficients exceeding 0.999. The average recovery of organic acids is in the range of 97.6% ∼ 103.1%, and the relative standard deviation is in the range of 0.037% ∼ 0.38%. The method is subsequently applied to obtain organic acid profiles of uridine 5'-monophosphate culture broth fermented from orotic acid by Saccharomyces cerevisiae. These data demonstrate the quantitative accuracy for nucleotide fermentation mixtures, and suggest that the method may also be applicable to other biological samples.

Downstream extraction process development for recovery of organic acids from a fermentation broth.

PubMed

Bekatorou, Argyro; Dima, Agapi; Tsafrakidou, Panagiotia; Boura, Konstantina; Lappa, Katerina; Kandylis, Panagiotis; Pissaridi, Katerina; Kanellaki, Maria; Koutinas, Athanasios A

2016-11-01

The present study focused on organic acids (OAs) recovery from an acidogenic fermentation broth, which is the main problem regarding the use of OAs for production of ester-based new generation biofuels or other applications. Specifically, 10 solvents were evaluated for OAs recovery from aqueous media and fermentation broths. The effects of pH, solvent/OAs solution ratios and application of successive extractions were studied. The 1:1 solvent/OAs ratio showed the best recovery rates in most cases. Butyric and isobutyric acids showed the highest recovery rates (80-90%), while lactic, succinic, and acetic acids were poorly recovered (up to 45%). The OAs recovery was significantly improved by successive 10-min extractions. Alcohols presented the best extraction performance. The process using repeated extractions with 3-methyl-1-butanol led to the highest OAs recovery. However, 1-butanol can be considered as the most cost-effective option taking into account its price and availability. Copyright © 2016 Elsevier Ltd. All rights reserved.

New HPV Serology Laboratory Aims to Standardize Assays and Contribute to Vaccine Implementation and Access | Frederick National Laboratory for Cancer Research

Cancer.gov

A new international initiative, led by scientists at the Frederick National Laboratory for Cancer Research and several other institutions, is being launched to provide expertise and leadership on the development, validation, and standardization of hu

Membrane-based recovery and dehydration of alcohols from fermentation broths - of materials and modules

EPA Science Inventory

Distillation combined with molecular sieve dehydration is the current state of the art for fuel grade ethanol production from fermentation broths. As the liquid biofuels industry transitions to lignocellulosic feedstocks, expands the end product portfolio to include other alcoho...

The OSHA Hazardous Chemical Occupational Exposure Standard for Laboratories - A New Management Regulation to Ensure Employee Health

DTIC Science & Technology

1991-04-01

Hazardous Chemical Occupational Exposur PE - 87714F Standard for Laboratories- A New Management Regu- PR - SUPT lation to Ensure Employee Health TA - XX 6...produce acute or chronic adverse health effects in sional visitors such as guests or sales personnel. exposed workers . Health hazards include...standard is to safeguard the health and well- place and increases the likelihood of exposure. being of laboratory workers . The welfare of our person- A

Paradigm Diagnostics Salmonella Indicator Broth (PDX-SIB) for detection of Salmonella on selected environmental surfaces.

PubMed

Olstein, Alan; Griffith, Leena; Feirtag, Joellen; Pearson, Nicole

2013-01-01

The Paradigm Diagnostics Salmonella Indicator Broth (PDX-SIB) is intended as a single-step selective enrichment indicator broth to be used as a simple screening test for the presence of Salmonella spp. in environmental samples. This method permits the end user to avoid multistep sample processing to identify presumptively positive samples, as exemplified by standard U.S. reference methods. PDX-SIB permits the outgrowth of Salmonella while inhibiting the growth of competitive Gram-negative and -positive microflora. Growth of Salmonella-positive cultures results in a visual color change of the medium from purple to yellow when the sample is grown at 37 +/- 1 degree C. Performance of PDX-SIB has been evaluated in five different categories: inclusivity-exclusivity, methods comparison, ruggedness, lot-to-lot variability, and shelf stability. The inclusivity panel included 100 different Salmonella serovars, 98 of which were SIB-positive during the 30 to 48 h incubation period. The exclusivity panel included 33 different non-Salmonella microorganisms, 31 of which were SIB-negative during the incubation period. Methods comparison studies included four different surfaces: S. Newport on plastic, S. Anatum on sealed concrete, S. Abaetetuba on ceramic tile, and S. Typhimurium in the presence of 1 log excess of Citrobacter freundii. Results of the methods comparison studies demonstrated no statistical difference between the SIB method and the U.S. Food and Drug Administration-Bacteriological Analytical Manual reference method, as measured by the Mantel-Haenszel Chi-square test. Ruggedness studies demonstrated little variation in test results when SIB incubation temperatures were varied over a 34-40 degrees C range. Lot-to-lot consistency results suggest no detectable differences in manufactured goods using two reference Salmonella serovars and one non-Salmonella microorganism.

Impact of boiling conditions on the molecular and sensory profile of a vegetable broth.

PubMed

Mougin, Alice; Mauroux, Olivier; Matthey-Doret, Walter; Barcos, Eugenia Maria; Beaud, Fernand; Bousbaine, Ahmed; Viton, Florian; Smarrito-Menozzi, Candice

2015-02-11

Low-pressure cooking has recently been identified as an alternative to ambient and high-pressure cooking to provide food with enhanced organoleptic properties. This work investigates the impact of the cooking process at different pressures on the molecular and sensory profile of a vegetable broth. Experimental results showed similar sensory and chemical profiles of vegetable broths when boiling at 0.93 and 1.5 bar, while an enhancement of sulfur volatile compounds correlated with a greater leek content and savory aroma was observed when boiling at low pressure (80 °C/0.48 bar). Thus, low-pressure cooking would allow preserving the most labile volatiles likely due to the lower water boiling temperature and the reduced level of oxygen. This study evidenced chemical and sensory impact of pressure during cooking and demonstrated that the flavor profile of culinary preparations can be enhanced by applying low-pressure conditions.

Use of liquid/supercritical CO2 extraction process for butanol recovery from fermentation broth

USDA-ARS?s Scientific Manuscript database

In order for butanol fermentation to be a viable option, it is essential to recover it from fermentation broth using economical alternate in-situ product recovery techniques such as liquid/supercritical CO2 extraction as compared to distillation. This technique (liquid CO2 extraction & supercritical...

Validation of Sensititre Dry-Form Broth Microdilution Panels for Susceptibility Testing of Ceftazidime-Avibactam, a Broad-Spectrum-β-Lactamase Inhibitor Combination

PubMed Central

Holliday, Nicole M.; Krause, Kevin M.

2015-01-01

Ceftazidime-avibactam is a broad-spectrum-β-lactamase inhibitor combination in late-stage clinical development for the treatment of serious infections. In preparation for clinical microbiology laboratory use, a validation experiment was initiated to evaluate a commercial broth microdilution product (Sensititre dried MIC susceptibility system) compared to reference panels using 525 recent clinical isolates. Among 11 pathogen groups, all had Sensititre MIC/reference MIC ratios predominantly at 1 (47.5% to 97.5%), and automated and manual endpoint results did not differ. Enterobacteriaceae MIC comparisons showed a modest skewing of Sensititre MIC results toward an elevated MIC (33.9%), but the essential agreement was 98.9% with 100.0% reproducibility. In conclusion, Sensititre panels produced accurate ceftazidime-avibactam MIC results, allowing quality MIC guidance for therapy following regulatory approvals. PMID:26014937

Quantity quotient reporting. A proposal for a standardized presentation of laboratory results.

PubMed

Haeckel, Rainer; Wosniok, Werner

2009-01-01

Laboratory results are reported in different units (despite international recommendations for SI units) together with different reference limits, of which several exist for many quantities. It is proposed to adopt the concept of the intelligence quotient and to report quantitative results as a quantity quotient (QQ) in laboratory medicine. This quotient is essentially the difference (measured result minus mean or mode value of the reference interval) divided by the observed biological variation CV(o). Thus, all quantities are reported in the same unit system with the same reference limits (for convenience shifted to e.g., 80-120). The critical difference can also be included in this standardization concept. In this way the information of reference intervals and the original result are integrated into one combined value, which has the same format for all quantities suited for quotient reporting (QR). The proposal of QR does not interfere with neither the current concepts of traceability, SI units or method standardization. This proposal represents a further step towards harmonization of reporting. It provides simple values which can be interpreted easily by physicians and their patients.

40 CFR 262.206 - Labeling and management standards for containers of unwanted material in the laboratory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Labeling and management standards for containers of unwanted material in the laboratory. 262.206 Section 262.206 Protection of Environment... the laboratory to assure safe storage of the unwanted material, to prevent leaks, spills, emissions to...

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

NASA Astrophysics Data System (ADS)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-04-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

PubMed

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Performance of the RAD-57 pulse CO-oximeter compared with standard laboratory carboxyhemoglobin measurement.

PubMed

Touger, Michael; Birnbaum, Adrienne; Wang, Jessica; Chou, Katherine; Pearson, Darion; Bijur, Polly

2010-10-01

We assess agreement between carboxyhemoglobin levels measured by the Rad-57 signal extraction pulse CO-oximeter (RAD), a Food and Drug Administration-approved device for noninvasive bedside measurement, and standard laboratory arterial or venous measurement in a sample of emergency department (ED) patients with suspected carbon monoxide poisoning. The study was a cross-sectional cohort design using a convenience sample of adult and pediatric ED patients in a Level I trauma, burn, and hyperbaric oxygen referral center. Measurement of RAD carboxyhemoglobin was performed simultaneously with blood sampling for laboratory determination of carboxyhemoglobin level. The difference between the measures for each patient was calculated as laboratory carboxyhemoglobin minus carboxyhemoglobin from the carbon monoxide oximeter. The limits of agreement from a Bland-Altman analysis are calculated as the mean of the differences between methods ±1.96 SDs above and below the mean. Median laboratory percentage carboxyhemoglobin level was 2.3% (interquartile range 1 to 8.5; range 0% to 38%). The mean difference between laboratory carboxyhemoglobin values and RAD values was 1.4% carboxyhemoglobin (95% confidence interval [CI] 0.2% to 2.6%). The limits of agreement of differences of measurement made with the 2 devices were -11.6% and 14.4% carboxyhemoglobin. This range exceeded the value of ±5% carboxyhemoglobin defined a priori as clinically acceptable. RAD correctly identified 11 of 23 patients with laboratory values greater than 15% carboxyhemoglobin (sensitivity 48%; 95% CI 27% to 69%). There was one case of a laboratory carboxyhemoglobin level less than 15%, in which the RAD device gave a result greater than 15% (specificity of RAD 96/97=99%; 95% CI 94% to 100%). In the range of carboxyhemoglobin values measured in this sample, the level of agreement observed suggests RAD measurement may not be used interchangeably with standard laboratory measurement. Copyright © 2010 American

Biological Pretreatment of Chicken Feather and Biogas Production from Total Broth.

PubMed

Patinvoh, Regina J; Feuk-Lagerstedt, Elisabeth; Lundin, Magnus; Sárvári Horváth, Ilona; Taherzadeh, Mohammad J

2016-12-01

Chicken feathers are available in large quantities around the world causing environmental challenges. The feathers are composed of keratin that is a recalcitrant protein and is hard to degrade. In this work, chicken feathers were aerobically pretreated for 2-8 days at total solid concentrations of 5, 10, and 20 % by Bacillus sp. C 4 , a bacterium that produces both α- and β-keratinases. Then, the liquid fraction (feather hydrolysate) as well as the total broth (liquid and solid fraction of pretreated feathers) was used as substrates for biogas production using anaerobic sludge or bacteria granules as inoculum. The biological pretreatment of feather waste was productive; about 75 % of feather was converted to soluble crude protein after 8 days of degradation at initial feather concentration of 5 %. Bacteria granules performed better during anaerobic digestion of untreated feathers, resulting in approximately two times more methane yield (i.e., 199 mlCH 4 /gVS compared to 105 mlCH 4 /gVS when sludge was used). Pretreatment improved methane yield by 292 and 105 % when sludge and granules were used on the hydrolysate. Bacteria granules worked effectively on the total broth, yielded 445 mlCH 4 /gVS methane, which is 124 % more than that obtained with the same type of inoculum from untreated feather.

HEW to Set Laboratory Safety Standards.

ERIC Educational Resources Information Center

Chemical and Engineering News, 1978

1978-01-01

Describes Department of Health, Education and Welfare (HEW) proposed guidelines for laboratories using chemical carcinogens. The guidelines are designed to provide protection for laboratory workers and their environment from exposure to all types of carcinogenic agents. (GA)

Assessment of tolerance induction by Origanum vulgare L. essential oil or carvacrol in Pseudomonas aeruginosa cultivated in a meat-based broth and in a meat model.

PubMed

da Silva Luz, Isabelle; Gomes-Neto, Nelson Justino; Magnani, Marciane; de Souza, Evandro Leite

2015-12-01

This study assessed the efficacy of Origanum vulgare L. essential oil (OVEO) and carvacrol in inhibiting the growth of Pseudomonas aeruginosa ATCC 9027, as well as the development of direct tolerance and cross-tolerance when this bacterium was challenged with sublethal amounts of these substances in a meat-based broth and in a meat model. OVEO and carvacrol at their minimum inhibitory concentrations (MICs), 1/2 MIC and 1/4 MIC decreased the viable cell counts of P. aeruginosa in meat-based broth. Direct tolerance or cross-tolerance was not induced after exposure of the assayed bacterial strain to sublethal amounts of OVEO or carvacrol in meat-based broth and in an artificially contaminated ground beef. Bacterial cells progressively subcultured in meat-based broth with increasing amounts of the tested substances survived up to the MIC of OVEO and to 1/2 MIC of carvacrol. The results reveal a lack of induction of tolerance in P. aeruginosa by exposure to OVEO or carvacrol in meat-based broth and in a meat model. © The Author(s) 2014.

The effects of calculator-based laboratories on standardized test scores

NASA Astrophysics Data System (ADS)

Stevens, Charlotte Bethany Rains

Nationwide, the goal of providing a productive science and math education to our youth in today's educational institutions is centering itself around the technology being utilized in these classrooms. In this age of digital technology, educational software and calculator-based laboratories (CBL) have become significant devices in the teaching of science and math for many states across the United States. Among the technology, the Texas Instruments graphing calculator and Vernier Labpro interface, are among some of the calculator-based laboratories becoming increasingly popular among middle and high school science and math teachers in many school districts across this country. In Tennessee, however, it is reported that this type of technology is not regularly utilized at the student level in most high school science classrooms, especially in the area of Physical Science (Vernier, 2006). This research explored the effect of calculator based laboratory instruction on standardized test scores. The purpose of this study was to determine the effect of traditional teaching methods versus graphing calculator teaching methods on the state mandated End-of-Course (EOC) Physical Science exam based on ability, gender, and ethnicity. The sample included 187 total tenth and eleventh grade physical science students, 101 of which belonged to a control group and 87 of which belonged to the experimental group. Physical Science End-of-Course scores obtained from the Tennessee Department of Education during the spring of 2005 and the spring of 2006 were used to examine the hypotheses. The findings of this research study suggested the type of teaching method, traditional or calculator based, did not have an effect on standardized test scores. However, the students' ability level, as demonstrated on the End-of-Course test, had a significant effect on End-of-Course test scores. This study focused on a limited population of high school physical science students in the middle Tennessee

Services of the CDRH X-ray calibration laboratory and their traceability to National Standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cerra, F.; Heaton, H.T.

The X-ray Calibration Laboratory (XCL) of the Center for Devices and Radiological Health (CDRH) provides calibration services for the Food and Drug Administration (FDA). The instruments calibrated are used by FDA and contract state inspectors to verify compliance with federal x-ray performance standards and for national surveys of x-ray trends. In order to provide traceability of measurements, the CDRH XCL is accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) for reference, diagnostic, and x-ray survey instrument calibrations. In addition to these accredited services, the CDRH XCL also calibrates non-invasive kVp meters in single- and three-phase x-ray beams, and thermoluminescentmore » dosimeter (TLD) chips used to measure CT beam profiles. The poster illustrates these services and shows the traceability links back to the National Standards.« less

Antifungal susceptibility of Malassezia furfur, Malassezia sympodialis, and Malassezia globosa to azole drugs and amphotericin B evaluated using a broth microdilution method.

PubMed

Rojas, Florencia D; Sosa, María de los A; Fernández, Mariana S; Cattana, María E; Córdoba, Susana B; Giusiano, Gustavo E

2014-08-01

We studied the in vitro activity of fluconazole (FCZ), ketoconazole (KTZ), miconazole (MCZ), voriconazole (VCZ), itraconazole (ITZ) and amphotericin B (AMB) against the three major pathogenic Malassezia species, M. globosa, M. sympodialis, and M. furfur. Antifungal susceptibilities were determined using the broth microdilution method in accordance with Clinical and Laboratory Standards Institute reference document M27-A3. To support lipid-dependent yeast development, glucose, peptone, ox bile, malt extract, glycerol, and Tween supplements were added to Roswell Park Memorial Institute RPMI 1640 medium. The supplemented medium allowed good growth of all three species studied. The minimal inhibitory concentrations (MICs) were recorded after 72 h of incubation at 32ºC. The three species showed different susceptibility profiles for the drugs tested. Malassezia sympodialis was the most susceptible and M. furfur the least susceptible species. KTZ, ITZ, and VCZ were the most active drugs, showing low variability among isolates of the same species. FCZ, MCZ, and AMB showed high MICs and wide MIC ranges. Differences observed emphasize the need to accurately identify and evaluate antifungal susceptibility of Malassezia species. Further investigations and collaborative studies are essential for correlating in vitro results with clinical outcomes since the existing limited data do not allow definitive conclusions. © The Author 2014. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.

PubMed

Lowe, Nancy K; Neal, Jeremy L; Ryan-Wenger, Nancy A

2009-01-01

To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard. This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard. Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult. II.

A laboratory comparison of individual Targis/Vectris posts with standard fiberglass posts.

PubMed

Corsalini, Massimo; Genovese, Katia; Lamberti, Luciano; Pappalettere, Carmine; Carella, Mauro; Carossa, Stefano

2007-01-01

This article presents an in vitro analysis of a specific occlusal loading test on endodontically treated teeth restored with 2 different composite post materials. Individual, customized posts (IFPs) were compared to standard fiberglass posts (SFPs). The selected IFPs (standard cylindric Targis/Vectris posts) were compared to SFPs (Conic 6% Post, Ghimas). The posts were first subjected to a 3-point bending test to compare their flexural elastic properties. They were then used to restore 22 endodontically treated artificial maxillary central incisors and subjected to a specific occlusal loading simulation test. The loading test showed that IFP restorations performed better than SFP restorations. A clinical evaluation of this laboratory observation is suggested.

Validation of Sensititre Dry-Form Broth Microdilution Panels for Susceptibility Testing of Ceftazidime-Avibactam, a Broad-Spectrum-β-Lactamase Inhibitor Combination.

PubMed

Jones, Ronald N; Holliday, Nicole M; Krause, Kevin M

2015-08-01

Ceftazidime-avibactam is a broad-spectrum-β-lactamase inhibitor combination in late-stage clinical development for the treatment of serious infections. In preparation for clinical microbiology laboratory use, a validation experiment was initiated to evaluate a commercial broth microdilution product (Sensititre dried MIC susceptibility system) compared to reference panels using 525 recent clinical isolates. Among 11 pathogen groups, all had Sensititre MIC/reference MIC ratios predominantly at 1 (47.5% to 97.5%), and automated and manual endpoint results did not differ. Enterobacteriaceae MIC comparisons showed a modest skewing of Sensititre MIC results toward an elevated MIC (33.9%), but the essential agreement was 98.9% with 100.0% reproducibility. In conclusion, Sensititre panels produced accurate ceftazidime-avibactam MIC results, allowing quality MIC guidance for therapy following regulatory approvals. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

First Comprehensive Evaluation of the M.I.C. Evaluator Device Compared to Etest and CLSI Broth Microdilution for MIC Testing of Aerobic Gram-Positive and Gram-Negative Bacterial Species

PubMed Central

Turnbull, L.; Brosnikoff, C.; Cloke, J.

2012-01-01

The M.I.C. Evaluator strip (Thermo Fisher Scientific, Basingstoke, United Kingdom) uses a methodology similar to that of Etest. In this first assessment of the M.I.C. Evaluator device, 409 strains of aerobic Gram-positive bacteria (staphylococci, streptococci, and enterococci) and 325 strains of Enterobacteriaceae, Pseudomonas species, and Acinetobacter species were tested by M.I.C. Evaluator strip, Etest, and broth microdilution as a reference standard. The Gram-positive bacteria included staphylococci (methicillin-resistant Staphylococcus aureus, methicillin-susceptible S. aureus, and coagulase-negative staphylococci), Streptococcus pneumoniae, beta-hemolytic streptococci and viridians group strains, vancomycin-resistant enterococci, and other enterococci. The Gram-negative bacteria included 250 strains of 60 Enterobacteriaceae species plus 50 Pseudomonas and 25 Acinetobacter species. A total of 14 antimicrobial agents (depending on the species) were included. The same methodology and reading format were used for M.I.C. Evaluator strips and Etest. Broth microdilution methodology was performed according to CLSI document M07-A8. For the clinical strains, >95% of results were plus or minus one doubling dilution for all species. There were fewer than 5% minor errors, fewer than 3% major errors, and fewer than 1% very major errors. M.I.C. Evaluator strips and Etest often reported higher MICs than the reference broth microdilution method. The M.I.C. Evaluator strips provided results comparable to those of the predicate Etest device and are of value for the accurate testing of MICs for these important pathogens. PMID:22238441

Paving the way for a gold standard of care for infertility treatment: improving outcomes through standardization of laboratory procedures.

PubMed

Schoolcraft, William; Meseguer, Marcos

2017-10-01

Infertility affects over 70 million couples globally. Access to, and interest in, assisted reproductive technologies is growing worldwide, with more couples seeking medical intervention to conceive, in particular by IVF. Despite numerous advances in IVF techniques since its first success in 1978, almost half of the patients treated remain childless. The multifactorial nature of IVF treatment means that success is dependent on many variables. Therefore, it is important to examine how each variable can be optimized to achieve the best possible outcomes for patients. The current approach to IVF is fragmented, with various protocols in use. A systematic approach to establishing optimum best practices may improve IVF success and live birth rates. Our vision of the future is that technological advancements in the laboratory setting are standardized and universally adopted to enable a gold standard of care. Implementation of best practices for laboratory procedures will enable clinicians to generate high-quality gametes, and to produce and identify gametes and embryos of maximum viability and implantation potential, which should contribute to improving take-home healthy baby rates. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Energy efficient recovery and dehydration of ethanol from fermentation broths by Membrane Assisted Vapor Stripping technology

EPA Science Inventory

Distillation combined with molecular sieve dehydration is the current state of the art for fuel grade ethanol production from fermentation broths. To improve the sustainability of bioethanol production, energy efficient separation alternatives are needed, particularly for lower ...

Determination of minimum inhibitory concentrations of itraconazole, terbinafine and ketoconazole against dermatophyte species by broth microdilution method.

PubMed

Bhatia, V K; Sharma, P C

2015-01-01

Various antifungal agents both topical and systemic have been introduced into clinical practice for effectively treating dermatophytic conditions. Dermatophytosis is the infection of keratinised tissues caused by fungal species of genera Trichophyton, Epidermophyton and Microsporum, commonly known as dermatophytes affecting 20-25% of the world's population. The present study aims at determining the susceptibility patterns of dermatophyte species recovered from superficial mycoses of human patients in Himachal Pradesh to antifungal agents; itraconazole, terbinafine and ketoconazole. The study also aims at determining the minimum inhibitory concentrations (MICs) of these agents following the recommended protocol of Clinical and Laboratory Standards Institute (CLSI) (M38-A2). A total of 53 isolates of dermatophytes (T. mentagrophyte-34 in no., T. rubrum-18 and M. gypseum-1) recovered from the superficial mycoses were examined. Broth microdilution method M38-A2 approved protocol of CLSI (2008) for filamentous fungi was followed for determining the susceptibility of dermatophyte species. T. mentagrophyte isolates were found more susceptible to both itraconazole and ketoconazole as compared to terbinafine (MIC50: 0.125 µg/ml for itraconazole, 0.0625 µg/ml for ketoconazole and 0.5 µg/ml for terbinafine). Three isolates of T. mentagrophytes (VBS-5, VBSo-3 and VBSo-73) and one isolate of T. rubrum (VBPo-9) had higher MIC values of itraconazole (1 µg/ml). Similarly, the higher MIC values of ketoconazole were observed in case of only three isolates of T. mentagrophyte (VBSo-30 = 2 µg/ml; VBSo-44, VBM-2 = 1 µg/ml). The comparative analysis of the three antifungal drugs based on t-test revealed that 'itraconazole and terbinafine' and 'terbinafine and ketoconazole' were found independent based on the P < 0.005 in case of T. mentagrophyte isolates. In case of T. rubrum, the similarity existed between MIC values of 'itraconazole and ketoconazole' and 'terbinafine and

Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.

PubMed

Feller, Etty

2008-01-01

Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Economic Co-operation and Development (OECD). Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. The similarities and differences between the ISO/IEC 17025 standard and the OECD principles of GLP are compared and discussed.

Extraction of natural red colorants from the fermented broth of Penicillium purpurogenum using aqueous two-phase polymer systems.

PubMed

Santos-Ebinuma, Valéria Carvalho; Lopes, André Moreni; Pessoa, Adalberto; Teixeira, Maria Francisca Simas

2015-01-01

Safety concerns related to the increasing and widespread application of synthetic coloring agents have increased the demand for natural colorants. Fungi have been employed in the production of novel and safer colorants. In order to obtain the colorants from fermented broth, suitable extraction systems must be developed. Aqueous two-phase polymer systems (ATPPS) offer a favorable chemical environment and provide a promising alternative for extracting and solubilizing these molecules. The aim of this study was to investigate the partitioning of red colorants from the fermented broth of Penicillium purpurogenum using an ATPPS composed of poly(ethylene glycol) (PEG) and sodium polyacrylate (NaPA). Red colorants partitioned preferentially to the top (PEG-rich phase). In systems composed of PEG 6,000 g/mol/NaPA 8,000 g/mol, optimum colorant partition coefficient (KC ) was obtained in the presence of NaCl 0.1 M (KC  = 10.30) while the PEG 10,000 g/mol/NaPA 8,000 g/mol system in the presence of Na2 SO4 0.5 M showed the highest KC (14.78). For both polymers, the mass balance (%MB) and yield in the PEG phase (%ηTOP ) were close to 100 and 79%, respectively. The protein selectivity in all conditions evaluated ranged from 2.0-3.0, which shows a suitable separation of the red colorants and proteins present in the fermented broth. The results suggest that the partitioning of the red colorants is dependent on both the PEG molecular size and salt type. Furthermore, the results obtained support the potential application of ATPPS as the first step of a purification process to recover colorants from fermented broth of microorganisms. © 2015 American Institute of Chemical Engineers.

Electronic laboratory quality assurance program: A method of enhancing the prosthodontic curriculum and addressing accreditation standards.

PubMed

Moghadam, Marjan; Jahangiri, Leila

2015-08-01

An electronic quality assurance (eQA) program was developed to replace a paper-based system and to address standards introduced by the Commission on Dental Accreditation (CODA) and to improve educational outcomes. This eQA program provides feedback to predoctoral dental students on prosthodontic laboratory steps at New York University College of Dentistry. The purpose of this study was to compare the eQA program of performing laboratory quality assurance with the former paper-based format. Fourth-year predoctoral dental students (n=334) who experienced both the paper-based and the electronic version of the quality assurance program were surveyed about their experiences. Additionally, data extracted from the eQA program were analyzed to identify areas of weakness in the curriculum. The study findings revealed that 73.8% of the students preferred the eQA program to the paper-based version. The average number of treatments that did not pass quality assurance standards was 119.5 per month. This indicated a 6.34% laboratory failure rate. Further analysis of these data revealed that 62.1% of the errors were related to fixed prosthodontic treatment, 27.9% to partial removable dental prostheses, and 10% to complete removable dental prostheses in the first 18 months of program implementation. The eQA program was favored by dental students who have experienced both electronic and paper-based versions of the system. Error type analysis can yield the ability to create customized faculty standardization sessions and refine the didactic and clinical teaching of the predoctoral students. This program was also able to link patient care activity with the student's laboratory activities, thus addressing the latest requirements of the CODA regarding the competence of graduates in evaluating laboratory work related to their patient care. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

75 FR 75485 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-03

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... Laboratories and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing

PubMed Central

Cirillo, Daniela M.; Hoffner, Sven; Ismail, Nazir A.; Kaur, Devinder; Lounis, Nacer; Metchock, Beverly; Pfyffer, Gaby E.; Venter, Amour

2016-01-01

The aim of this study was to establish standardized drug susceptibility testing (DST) methodologies and reference MIC quality control (QC) ranges for bedaquiline, a diarylquinoline antimycobacterial, used in the treatment of adults with multidrug-resistant tuberculosis. Two tier-2 QC reproducibility studies of bedaquiline DST were conducted in eight laboratories using Clinical Laboratory and Standards Institute (CLSI) guidelines. Agar dilution and broth microdilution methods were evaluated. Mycobacterium tuberculosis H37Rv was used as the QC reference strain. Bedaquiline MIC frequency, mode, and geometric mean were calculated. When resulting data occurred outside predefined CLSI criteria, the entire laboratory data set was excluded. For the agar dilution MIC, a 4-dilution QC range (0.015 to 0.12 μg/ml) centered around the geometric mean included 95.8% (7H10 agar dilution; 204/213 observations with one data set excluded) or 95.9% (7H11 agar dilution; 232/242) of bedaquiline MICs. For the 7H9 broth microdilution MIC, a 3-dilution QC range (0.015 to 0.06 μg/ml) centered around the mode included 98.1% (207/211, with one data set excluded) of bedaquiline MICs. Microbiological equivalence was demonstrated for bedaquiline MICs determined using 7H10 agar and 7H11 agar but not for bedaquiline MICs determined using 7H9 broth and 7H10 agar or 7H9 broth and 7H11 agar. Bedaquiline DST methodologies and MIC QC ranges against the H37Rv M. tuberculosis reference strain have been established: 0.015 to 0.12 μg/ml for the 7H10 and 7H11 agar dilution MICs and 0.015 to 0.06 μg/ml for the 7H9 broth microdilution MIC. These methodologies and QC ranges will be submitted to CLSI and EUCAST to inform future research and provide guidance for routine clinical bedaquiline DST in laboratories worldwide. PMID:27654337

Radiation sensitivity of poliovirus, a model for norovirus, inoculated in oyster ( Crassostrea gigas) and culture broth under different conditions

NASA Astrophysics Data System (ADS)

Jung, Pil-Mun; Park, Jae Seok; Park, Jin-Gyu; Park, Jae-Nam; Han, In-Jun; Song, Beom-Seok; Choi, Jong-il; Kim, Jae-Hun; Byun, Myung-Woo; Baek, Min; Chung, Young-Jin; Lee, Ju-Woon

2009-07-01

Poliovirus is a recognized surrogate for norovirus, pathogen in water and food, due to the structural and genetic similarity. Although radiation sensitivity of poliovirus in water or media had been reported, there has been no research in food model such as shellfish. In this study, oyster ( Crassostrea gigas) was incubated in artificial seawater contaminated with poliovirus, and thus radiation sensitivity of poliovirus was determined in inoculated oyster. The effects of ionizing radiation on the sensitivity of poliovirus were also evaluated under different conditions such as pH (4-7) and salt concentration (1-15%) in culture broth, and temperature during irradiation. The D10 value of poliovirus in PBS buffer, virus culture broth and oyster was determined to 0.46, 2.84 and 2.94 kGy, respectively. The initial plaque forming unit (PFU) of poliovirus in culture broth was slightly decreased as the decrease of pH and the increase of salt concentration, but radiation sensitivity was not affected by pH and salt contents. However, radiation resistance of poliovirus was increased at frozen state. These results provide the basic information for the inactivation of pathogenic virus in foods by using irradiation.

Preparative isolation and purification of anti-tumor agent ansamitocin P-3 from fermentation broth of Actinosynnema pretiosum using high-performance counter-current chromatography.

PubMed

Yao, Yuqin; Cheng, Zhihui; Ye, Haoyu; Xie, Yongmei; He, Jing; Tang, Minghai; Shen, Tao; Wang, Jiangman; Zhou, Yan; Lu, Zejun; Luo, Feng; Chen, Lijuan; Yu, Luoting; Yang, Jin-Liang; Peng, Aihua; Wei, Yuquan

2010-05-01

Ansamitocin P-3 is a potent anti-tumor maytansinoid found in Actinosynnema pretiosum. However, due to the complexity of the fermentation broth of Actinomycete, how to effectively separate ansamitocin P-3 is still a challenge. In this study, both analytical and preparative high-performance counter-current chromatography were successfully used to separate and purify ansamitocin P-3 from fermentation broth. A total of 28.8 mg ansamitocin P-3 with purity of 98.4% was separated from 160 mg crude sample of fermentation broth in less than 80 min with the two-phase solvent system of hexane-ethyl acetate-methanol-water (0.6:1:0.6:1, v/v/v/v). The purity and structural identification were determined by HPLC, (1)H NMR, (13)C NMR and mass spectroscopy.

2,3-Butanediol recovery from fermentation broth by alcohol precipitation and vacuum distillation.

PubMed

Jeon, Sangjun; Kim, Duk-Ki; Song, Hyohak; Lee, Hee Jong; Park, Sunghoon; Seung, Doyoung; Chang, Yong Keun

2014-04-01

This study presents a new and effective downstream process to recover 2,3-butanediol (2,3-BD) from fermentation broth which is produced by a recombinant Klebsiella pneumoniae strain. The ldhA-deficient K. pneumoniae strain yielded about 90 g/L of 2,3-BD, along with a number of by-products, such as organic acids and alcohols, in a 65 h fed-batch fermentation. The pH-adjusted cell-free fermentation broth was firstly concentrated until 2,3-BD reached around 500 g/L by vacuum evaporation at 50°C and 50 mbar vacuum pressure. The concentrated solution was further treated using light alcohols, including methanol, ethanol, and isopropanol, for the precipitation of organic acids and inorganic salts. Isopropanol showed the highest removal efficiency, in which 92.5% and 99.8% of organic acids and inorganic salts were precipitated, respectively. At a final step, a vacuum distillation process enabled the recovery of 76.2% of the treated 2,3-BD, with 96.1% purity, indicating that fermentatively produced 2,3-BD is effectively recovered by a simple alcohol precipitation and vacuum distillation. Copyright © 2013 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

Inactivation of Staphylococcus aureus and Salmonella enteritidis in tryptic soy broth and caviar samples by high pressure processing.

PubMed

Fioretto, F; Cruz, C; Largeteau, A; Sarli, T A; Demazeau, G; El Moueffak, A

2005-08-01

We studied the action of high pressure processing on the inactivation of two foodborne pathogens, Staphylococcus aureus ATCC 6538 and Salmonella enteritidis ATCC 13076, suspended in a culture medium and inoculated into caviar samples. The baroresistance of the two pathogens in a tryptic soy broth suspension at a concentration of 10(8)-10(9) colony-forming units/ml was tested for continuous and cycled pressurization in the 150- to 550-MPa range and for 15-min treatments at room temperature. The increase of cycle number permitted the reduction of the pressure level able to totally inactivate both microorganisms in the tryptic soy broth suspension, whereas the effect of different procedure times on complete inactivation of the microorganisms inoculated into caviar was similar.

Intra-building telecommunications cabling standards for Sandia National Laboratories, New Mexico

DOE Office of Scientific and Technical Information (OSTI.GOV)

Adams, R.L.

1993-08-01

This document establishes a working standard for all telecommunications cable installations at Sandia National Laboratories, New Mexico. It is based on recent national commercial cabling standards. The topics addressed are Secure and Open/Restricted Access telecommunications environments and both twisted-pair and optical-fiber components of communications media. Some of the state-of-the-art technologies that will be supported by the intrabuilding cable infrastructure are Circuit and Packet Switched Networks (PBX/5ESS Voice and Low-Speed Data), Local Area Networks (Ethernet, Token Ring, Fiber and Copper Distributed Data Interface), and Wide Area Networks (Asynchronous Transfer Mode). These technologies can be delivered to every desk and can transportmore » data at rates sufficient to support all existing applications (such as Voice, Text and graphics, Still Images, Full-motion Video), as well as applications to be defined in the future.« less

Impact of preheating on the behavior of Listeria monocytogenes in a broth that mimics Camembert cheese composition.

PubMed

Helloin, E; Bouttefroy, A; Gay, M; Phan Thanh, L

2003-02-01

The effect of preheating on the survival of L. monocytogenes in Richard's broth, which mimics the composition of Camembert cheese composition, was examined. Experiments were carried out to reproduce contamination of cheese with environmental heat-stressed cells of L. monocytogenes surviving hot-cleaning procedures. Cells in mid-log phase were heated for 30 min at 56 degrees C before being inoculated into Richard's broth. The pHs and temperatures of Richard's broth were chosen to recreate the conditions of curd dripping (pH 5, 25 degrees C), of the beginning of cheese ripening (pH 5, 12 degrees C), and of the beginning (pH 5, 4 degrees C) and the end (pH 7, 4 degrees C) of cheese storage. Immediately after heat treatment, the viability loss was especially high for strain 306715, which exhibited only 0.6% +/- 0.2% survival, compared with 22% +/- 8.7% for strain EGD. The percentages of the surviving heated cells that were injured were 93% +/- 8% for strain 306715 and 98% +/- 3% for strain EGD. The destruction of the surviving L. monocytogenes cells was accelerated when they encountered the pH and temperature conditions of Camembert cheese during manufacturing, ripening, and cold storage (pH 5 at 25, 12, and 4 degrees C, respectively). The multiplication of the surviving heated cells was retarded under favorable growth conditions similar to those of storage by the distributor and the consumer (pH 7 at 4 and 12 degrees C, respectively).

LOINC, a universal standard for identifying laboratory observations: a 5-year update.

PubMed

McDonald, Clement J; Huff, Stanley M; Suico, Jeffrey G; Hill, Gilbert; Leavelle, Dennis; Aller, Raymond; Forrey, Arden; Mercer, Kathy; DeMoor, Georges; Hook, John; Williams, Warren; Case, James; Maloney, Pat

2003-04-01

The Logical Observation Identifier Names and Codes (LOINC) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems. For each observation, the database includes a code (of which 25 000 are laboratory test observations), a long formal name, a "short" 30-character name, and synonyms. The database comes with a mapping program called Regenstrief LOINC Mapping Assistant (RELMA(TM)) to assist the mapping of local test codes to LOINC codes and to facilitate browsing of the LOINC results. Both LOINC and RELMA are available at no cost from http://www.regenstrief.org/loinc/. The LOINC medical database carries records for >30 000 different observations. LOINC codes are being used by large reference laboratories and federal agencies, e.g., the CDC and the Department of Veterans Affairs, and are part of the Health Insurance Portability and Accountability Act (HIPAA) attachment proposal. Internationally, they have been adopted in Switzerland, Hong Kong, Australia, and Canada, and by the German national standards organization, the Deutsches Instituts für Normung. Laboratories should include LOINC codes in their outbound HL7 messages so that clinical and research clients can easily integrate these results into their clinical and research repositories. Laboratories should also encourage instrument vendors to deliver LOINC codes in their instrument outputs and demand LOINC codes in HL7 messages they get from reference laboratories to avoid the need to lump so many referral tests under the "send out lab" code.

Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

Cancer.gov

The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In

Spectral Irradiance Calibration in the Infrared. 11; Comparison of (alpha) Bootis and 1 Ceres with a Laboratory Standard

NASA Technical Reports Server (NTRS)

Witteborn, Fred C.; Cohen, Martin; Bregman, Jesse D.; Wooden, Diane H.; Heere, Karen; Shirley, Eric L.

1999-01-01

Infrared spectra of two celestial objects frequently used as flux standards are calibrated against an absolute laboratory flux standard at a spectral resolving power of 100 to 200. The spectrum of the KI.5 III star alpha Boo is measured from 3 to 30 microns, and that of the C-type asteroid 1 Ceres from 5 to 30 microns. While these "standard" spectra do not have the apparent precision of those based on calculated models, they do not require the assumptions involved in theoretical models of stars and asteroids. Specifically, they provide a model-independent means of calibrating celestial flux in the spectral range from 12 to 30 microns, where accurate absolute photometry is not available. The agreement found between the spectral shapes of alpha Boo and Ceres based on laboratory standards and those based on observed ratios to alpha CMa (Sirius) and alpha Lyr (Vega), flux-calibrated by theoretical modeling of these hot stars, strengthens our confidence in the applicability of the stellar models as primary irradiance standards.

Spectral Irradiance Calibration in the Infrared 11: Comparison of (alpha) Boo and 1 Ceres with a Laboratory Standard

NASA Technical Reports Server (NTRS)

Witteborn, Fred C.; Cohen, Martin; Bregman, Jess D.; Wooden, Diane; Heere, Karen; Shirley, Eric L.

1998-01-01

Infrared spectra of two celestial objects frequently used as flux standards are calibrated against an absolute laboratory flux standard at a spectral resolving power of 100 to 200. The spectrum of the K1.5III star, alpha Boo, is measured from 3 microns to 30 microns and that of the C-type asteroid, 1 Ceres, from 5 microns to 30 microns. While these 'standard' spectra do not have the apparent precision of those based on calculated models, they do not require the assumptions involved in theoretical models of stars and asteroids. Specifically they provide a model-independent means of calibrating celestial flux in the spectral range from 12 microns to 30 microns where accurate absolute photometry is not available. The agreement found between the spectral shapes of alpha Boo and Ceres based on laboratory standards, and those based on observed ratios to alpha CMa (Sirius) and alpha Lyr (Vega), flux calibrated by theoretical modeling of these hot stars strengthens our confidence in the applicability of the stellar models as primary irradiance standards.

Evaluation of a newly developed triple buffered peptone broth for detection of Salmonella in broiler feed

USDA-ARS?s Scientific Manuscript database

Lactose broth (LB) and buffered peptone (BP) are used as pre-enrichment media to recover Salmonella from feed. Bacterial utilization of feed carbohydrates results in the production of acidic byproducts causing a drop in the media pH which can injure or kill Salmonella and yield false negative resul...

Ethical and methodological standards for laboratory and medical biological rhythm research.

PubMed

Portaluppi, Francesco; Touitou, Yvan; Smolensky, Michael H

2008-11-01

The main objectives of this article are to update the ethical standards for the conduct of human and animal biological rhythm research and recommend essential elements for quality chronobiological research information, which should be especially useful for new investigators of the rhythms of life. A secondary objective is to provide for those with an interest in the results of chronobiology investigations, but who might be unfamiliar with the field, an introduction to the basic methods and standards of biological rhythm research and time series data analysis. The journal and its editors endorse compliance of all investigators to the principles of the Declaration of Helsinki of the World Medical Association, which relate to the conduct of ethical research on human beings, and the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, which relate to the conduct of ethical research on laboratory and other animals. The editors and the readers of the journal expect the authors of submitted manuscripts to have adhered to the ethical standards dictated by local, national, and international laws and regulations in the conduct of investigations and to be unbiased and accurate in reporting never-before-published research findings. Authors of scientific papers are required to disclose all potential conflicts of interest, particularly when the research is funded in part or in full by the medical and pharmaceutical industry, when the authors are stock-holders of the company that manufactures or markets the products under study, or when the authors are a recent or current paid consultant to the involved company. It is the responsibility of the authors of submitted manuscripts to clearly present sufficient detail about the synchronizer schedule of the studied subjects (i.e., the sleep-wake schedule, ambient light-dark cycle, intensity and spectrum of ambient light exposure, seasons when the research was

Rapid Identification of Laboratory Contamination with Mycobacterium tuberculosis Using Variable Number Tandem Repeat Analysis

PubMed Central

Gascoyne-Binzi, Deborah M.; Barlow, Rachael E. L.; Frothingham, Richard; Robinson, Grant; Collyns, Timothy A.; Gelletlie, Ruth; Hawkey, Peter M.

2001-01-01

Compared with solid media, broth-based mycobacterial culture systems have increased sensitivity but also have higher false-positive rates due to cross-contamination. Systematic strain typing is rarely undertaken because the techniques are technically demanding and the data are difficult to organize. Variable number tandem repeat (VNTR) analysis by PCR is rapid and reproducible. The digital profile is easily manipulated in a database. We undertook a retrospective study of Mycobacterium tuberculosis isolates collected over an 18-month period following the introduction of the BACTEC MGIT 960 system. VNTR allele profiles were determined with early positive broth cultures and entered into a database with the specimen processing date and other specimen data. We found 36 distinct VNTR profiles in cultures from 144 patients. Three common VNTR profiles accounted for 45% of true-positive cases. By combining VNTR results with specimen data, we identified nine cross-contamination incidents, six of which were previously unsuspected. These nine incidents resulted in 34 false-positive cultures for 29 patients. False-positive cultures were identified for three patients who had previously been culture positive for tuberculosis and were receiving treatment. Identification of cross-contamination incidents requires careful documentation of specimen data and good communication between clinical and laboratory staff. Automated broth culture systems should be supplemented with molecular analysis to identify cross-contamination events. VNTR analysis is reproducible and provides timely results when applied to early positive broth cultures. This method should ensure that patients are not placed on unnecessary tuberculosis therapy or that cases are not falsely identified as treatment failures. In addition, areas where existing procedures may be improved can be identified. PMID:11136751

The gallium melting-point standard: its role in manufacture and quality control of electronic thermometers for the clinical laboratory.

PubMed

Sostman, H E

1977-01-01

I discuss the traceability of calibration of electronic thermometers to thermometric constants of nature or to the National Bureau of Standards, form a manufacturer's basic standards through the manufacturing process to the user's laboratory. Useful electrical temperature sensors, their advantages, and means for resolving their disadvantages are described. I summarize our development of a cell for realizing the melting phase equilibrium of pure gallium (at 29.770 degrees C) as a thermometer calibration fixed point, and enumerate its advantages in the routine calibration verification of electrical thermometers in the clinical chemistry laboratory.

Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

PubMed

Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

2017-02-01

Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed

Determination of moxifloxacin anaerobic susceptibility breakpoints according to the Clinical and Laboratory Standards Institute guidelines.

PubMed

Ambler, Jane; Rennie, Robert; Poupard, James; Koeth, Laura; Stass, Heino; Endermann, Rainer; Choudhri, Shurjeel

2008-05-01

A summary of the key data presented to Clinical and Laboratory Standards Institute (CLSI, formerly National Committee for Clinical and Laboratory Standards) in determination of moxifloxacin anaerobic breakpoints is presented. The breakpoint analysis required review of a variety of data, including bacteriologic and clinical outcomes by MIC of anaerobic isolates from prospective clinical trials in patients with complicated intra-abdominal infections, human and animal pharmacokinetic/pharmacodynamic (PK/PD) information and in vitro models, MIC distributions of indicated organisms, and animal model efficacy data for strains with MIC values around prospective breakpoints. The compilation of the various components of this breakpoint analysis supports the US Food and Drug Administration (FDA) and CLSI moxifloxacin anaerobic breakpoints of < or =2 mg/L (susceptible), 4 mg/L (intermediate), and > or =8 mg/L (resistant), and provides information to European investigators for interpretation of MICs prior to establishment of the European Committee on Antimicrobial Susceptibility Testing breakpoints.

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution... Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (ii...) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution... Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (ii...) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or...

Species of Genus Ganoderma (Agaricomycetes) Fermentation Broth: A Novel Antioxidant and Antimicrobial Agent.

PubMed

Cilerdzic, Jasmina; Kosanic, Marijana; Stajić, Mirjana; Vukojevic, Jelena; Ranković, Branislav

2016-01-01

The bioactivity of Ganoderma lucidum basidiocarps has been well documented, but there are no data on the medicinal properties of its submerged cultivation broth nor on the other species of the genus Ganoderma. Thus the aim of this study was to test the potential antimicrobial and antioxidant activity of fermentation broth obtained after submerged cultivation of G. applanatum, G. carnosum, and G. lucidum. DPPH· scavenging ability, total phenols, and flavonoid contents were measured to determine the antioxidative potential of Ganoderma spp. fermentation filtrates, whereas their antimicrobial potential was studied using the microdilution method. DPPH· scavenging activity of G. lucidum fermentation filtrates was significantly higher than that of G. applanatum and G. carnosum, with the maximum (39.67%) obtained from strain BEOFB 432. This filtrate also contained the highest concentrations of phenols (134.89 μg gallic acid equivalents/mL) and flavonoids (42.20 μg quercetin equivalent/mL). High correlations between the activity and phenol content in the extracts showed that these compounds were active components of the antioxidative activity. G. lucidum strain BEOFB 432 was the most effective antibacterial agent, whereas strain BEOFB 434 has proven to be the most effective antifungal agent. The study showed that Ganoderma spp. fermentation filtrates are novel potent antioxidative and antimicrobial agents that could be obtained more quickly and cheaper than basidiocarps.

Standard Specifications for Language Laboratory.

ERIC Educational Resources Information Center

North Carolina State Dept. of Administration, Raleigh.

Specifications are presented covering the components of electronic and electro-mechanical equipment, non-electrical materials for the teacher-student positions, and other items of a miscellaneous nature to provide for a complete, workable language laboratory facility. Instructions for the use of specifications are included for the purchaser,…

42 CFR 493.1407 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... developed and used for each of the tests performed in the laboratory provide quality laboratory services for... results are found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

Analysis of mixtures of fatty acids and fatty alcohols in fermentation broth.

PubMed

Liu, Yilan; Chen, Ting; Yang, Maohua; Wang, Caixia; Huo, Weiyan; Yan, Daojiang; Chen, Jinjin; Zhou, Jiemin; Xing, Jianmin

2014-01-03

Microbial production of fatty acids and fatty alcohols has attracted increasing concerns because of energy crisis and environmental impact of fossil fuels. Therefore, simple and efficient methods for the extraction and quantification of these compounds become necessary. In this study, a high-performance liquid chromatography-refractive index detection (HPLC-RID) method was developed for the simultaneous quantification of fatty acids and fatty alcohols in these samples. The optimum chromatographic conditions are C18 column eluted with methanol:water:acetic acid (90:9.9:0.1, v/v/v); column temperature, 26°C; flow rate, 1.0mL/min. Calibration curves of all selected analytes showed good linearity (r(2)≥0.9989). The intra-day and inter-day relative standard deviations (RSDs) of the 10 compounds were less than 4.46% and 5.38%, respectively, which indicated that the method had good repeatability and precision. Besides, a method for simultaneous extraction of fatty acids and fatty alcohols from fermentation broth was optimized by orthogonal design. The optimal extraction conditions were as follows: solvent, ethyl acetate; solvent to sample ratio, 0.5:1; rotation speed, 2min at 260rpm; extraction temperature, 10°C. This study provides simple and fast methods to simultaneously extract and quantify fatty acids and fatty alcohols for the first time. It will be useful for the study of microbial production of these products. Copyright © 2013 Elsevier B.V. All rights reserved.

TREAT Asia Quality Assessment Scheme (TAQAS) to standardize the outcome of HIV genotypic resistance testing in a group of Asian laboratories

PubMed Central

Land, Sally; Cunningham, Philip; Zhou, Jialun; Frost, Kevin; Katzenstein, David; Kantor, Rami; Chen, Yi-Ming Arthur; Oka, Shinichi; DeLong, Allison; Sayer, David; Smith, Jeffery; Dax, Elizabeth M.; Law, Matthew

2010-01-01

The TREAT Asia (Therapeutics, Research, Education, and AIDS Training in Asia) Network is building capacity for Human Immunodeficiency Virus Type-1 (HIV-1) drug resistance testing in the region. The objective of the TREAT Asia Quality Assessment Scheme – designated TAQAS – is to standardize HIV-1 genotypic resistance testing (HIV genotyping) among laboratories to permit rigorous comparison of results from different clinics and testing centres. TAQAS has evaluated three panels of HIV-1-positive plasma from clinical material or low-passage, culture supernatant for up to 10 Asian laboratories. Laboratory participants used their standard protocols to perform HIV genotyping. Assessment was in comparison to a target genotype derived from all participants and the reference laboratory’s result. Agreement between most participants at the edited nucleotide sequence level was high (>98%). Most participants performed to the reference laboratory standard in detection of drug resistance mutations (DRMs). However, there was variation in the detection of nucleotide mixtures (0–83%) and a significant correlation with the detection of DRMs (p < 0.01). Interpretation of antiretroviral resistance showed ~70% agreement among participants when different interpretation systems were used but >90% agreement with a common interpretation system, within the Stanford University Drug Resistance Database. Using the principles of external quality assessment and a reference laboratory, TAQAS has demonstrated high quality HIV genotyping results from Asian laboratories. PMID:19490972

Improved compliance with reporting standards: A retrospective analysis of Intersocietal Accreditation Commission Nuclear Cardiology Laboratories.

PubMed

Maddux, P Tim; Farrell, Mary Beth; Ewing, Joseph A; Tilkemeier, Peter L

2018-06-01

In 2011, Tilkemeier et al reported significant nuclear cardiology laboratory noncompliance with reporting standards. The aim of this study was to identify and examine noncompliant reporting elements with the Intersocietal Accreditation Commission Nuclear/PET (IAC) Reporting Standards and to compare compliance between 2008 and 2014. This was a retrospective study of compliance with 18 reporting elements utilizing accreditation findings from all laboratories applying for accreditation in 2008 and 2014. 1816 labs applying for initial or subsequent accreditation were analyzed for compliance. The mean reporting noncompliance per lab decreased from 2008 to 2014 (2.48 ± 2.67 to 1.24 ± 1.79, P < .001). Noncompliance decreased across lab types, labs with Certification Board of Nuclear Cardiology physicians on staff, and by geographic region (P < .001). Overall severity of reporting issues decreased. Facilities with compliant reports increased from 35.0% in 2008 to 57.1% in 2014 (P < .001). Continuing medical education, accreditation, and other instructional activities aimed at improving nuclear cardiology reporting appear to have made a positive impact over time with the number and severity of noncompliance decreased. More labs are now compliant with the IAC Standards and, thus, reporting guidelines. However, the need for continued educational efforts remains.

Selective enumeration of propionibacteria in Emmental-type cheese using Petrifilm™ aerobic count plates added to lithium glycerol broth.

PubMed

de Freitas, Rosângela; Luiz, Lívia M Pinheiro; Alves, Maura Pinheiro; Valence-Bertel, Florence; Nero, Luís Augusto; de Carvalho, Antônio Fernandes

2013-08-01

Propionibacteria derived from dairy products are relevant starter cultures for the production of Swiss and Emmental-type cheeses, and the monitoring of which is mandatory for proper quality control. This study aimed to evaluate an alternative procedure to enumerate propionibacteria, in order to develop a reliable and practical methodology to be employed by dairy industries. 2,3,5-triphenyltetrazolium chloride (TTC) inhibitory activity was tested against five reference strains (CIRM 09, 38, 39, 40 and 116); TTC at 0·0025% (w/v) was not inhibitory, with the exception of one strain (CIRM 116). Subsequently, the four TTC-resistant strains, three commercial starter cultures (PS-1, PB-I, and CHOO) and twelve Emmental-type cheese samples were subjected to propionibacteria enumeration using Lithium Glycerol (LG) agar, and Petrifilm™ Aerobic Count (AC) plates added to LG broth (anaerobic incubation at 30 °C for 7 d). Petrifilm™ AC added to LG broth presented high counts than LG agar (P<0·05) for only two reference strains (CIRM 39, and 40) and for all commercial starter cultures. Cheese sample counts obtained by both procedures did not show significant differences (P<0·05). Significant correlation indexes were observed between the counts recorded by both methods (P<0·05). These results demonstrate the reliability of Petrifilm™ AC plates added to LG broth in enumerating select Propionibacterium spp., despite some limitations observed for specific commercial starter cultures.

Effect of a novel steroid (PM-9) on the inhibition of 5alpha-reductase present in Penicillium crustosum broths.

PubMed

Flores, Eugenio; Cabeza, Marisa; Quiroz, Alexandra; Bratoeff, Eugene; García, Genoveva; Ramírez, Elena

2003-03-01

The conversion of testosterone (T) to 5alpha-dihydrotestosterone (DHT) has been demonstrated in Penicillium crustosum broth obtained from fermented pistachios, lemons and corn tortillas. Furthermore, the presence of 5alpha-reductase enzyme, which is responsible for this conversion, has been established by electrophoretical techniques in these cultures.5alpha-Reductase enzyme is also present in animal and human androgen-dependent tissues as well as in prostate and seminal vesicles. The increase of the conversion of T to DHT in prostate gland, has been related to some illnesses such as benign prostate hyperplasia and prostate cancer. Furthermore, treatment with 5alpha-reductase inhibitors such as finasteride reduces the prostate growth. These data have stimulated research for the synthesis of new molecules with antiandrogenic activity, whose biological effect needs to be demonstrated. The purpose of this study is to determine the inhibition pattern of 5alpha-reductase in P. crustosum by finasteride and the new steroidal compound PM-9. K(m) and V(max) values for T, were determined in the broths by Lineweaver-Burk plots using different testosterone concentrations. The inhibition pattern of finasteride and PM-9 was also determined by Lineweaver-Burk using different concentrations of T and inhibitors. Results show that finasteride and PM-9 inhibit 5alpha-reductase present in the broth in a competitive manner.

Combination of Origanum vulgare L. essential oil and lactic acid to inhibit Staphylococcus aureus in meat broth and meat model

PubMed Central

de Barros, Jefferson C.; da Conceição, Maria Lúcia; Neto, Nelson Justino Gomes; da Costa, Ana Caroliny Vieira; de Souza, Evandro Leite

2012-01-01

This study assessed the occurrence of an enhancing inhibitory effect of the combined application of Origanum vulgare L. essential oil and lactic acid against Staphylococcus aureus by the determination of Fractional Inhibitory Concentration (FIC) index and cell viability in meat broth and meat model. Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) of the oil was 0.6 and 1.25 µL.mL-1, respectively. Lactic acid showed MIC and MBC of 2.5 and 5µL.mL-1, respectively. FIC indices of the combined application of the oil and lactic acid were 0.5 showing a synergic interaction. The essential oil and lactic acid showed similar (p>0.05) anti-S. aureus effect in meat broth over 96 h of exposure. Treatment with essential oil or lactic acid presented a smaller anti-staphylococcal effect in meat in comparison to meat broth. No significant difference (p>0.05) was found for the microbial counts in meat treated with each antimicrobial alone or in mixture. These results could arise as an interesting approach for the improvement of food preservation using more natural procedures, considering the current demand of consumer and sensory quality of foods. PMID:24031936

Antitumor Compounds from the Stout Camphor Mushroom Taiwanofungus camphoratus (Higher Basidiomycetes) Spent Culture Broth.

PubMed

Jia, Wei; Bai, Yan-Yan; Zhang, Zhong; Feng, Na; Feng, Jie; Yan, Meng-Qiu; Zhu, Li-Na; Jia, Xin-Cheng; Wang, Ming-Dao; Zhang, Jing-song; Fan, Hua

2015-01-01

A known compound, 5-(hydroxymethyl) furan-2-carbaldehyde, and a novel compound, 3-isobutyl-1-methoxy-4-(4'-(3-methylbut-2-enyloxy)phenyl)-1H-pyrrole-2,5-dione were isolated from spent broth from submerged cultures of Taiwanofungus camphoratus. Their structures were elucidated by nuclear magnetic resonance (1H, 13C, and 2D) and mass spectra. These compounds inhibited the proliferation of K562 and HepG2 tumor cells in vitro.

Self-assembling systems based on quaternized derivatives of 1,4-diazabicyclo[2.2.2]octane in nutrient broth as antimicrobial agents and carriers for hydrophobic drugs.

PubMed

Pashirova, Tatiana N; Lukashenko, Svetlana S; Zakharov, Sergey V; Voloshina, Alexandra D; Zhiltsova, Elena P; Zobov, Vladimir V; Souto, Eliana B; Zakharova, Lucia Ya

2015-03-01

Aggregation properties of mono (mono-CS) and dicationic (di-CS) surfactants, namely quaternised derivatives of 1,4-diazabicyclo[2.2.2]octane (DABCO), have been evaluated in water and in nutrient broths of different pH, i.e. in Hottinger broth (рН=7.2) and Sabouraud dextrose broth (рН=5.6). Aggregation capacity of surfactants was shown to be responsible for the solubilization properties of a complex composed of a hydrophobic probe (Sudan I) and a selected drug (quercetin), contributing to the antimicrobial activity of this surfactant system. The effect of N-methyl-d-glucamine (NmDg) additive on the antimicrobial activity of mono-CS, and its aggregation and solubilization parameters, has also been evaluated. A substantial decrease in critical micelle concentration (CMC) of cationic surfactants in nutrient broths (up to 60 times) has been reported. Twofold dilution of monocationic surfactant by NmDg slightly changed the CMC of surfactant; however, it provided a remarkable increase in solubilization capacity (∼by 4 times) and decrease in its toxicity. The data anticipate the potential use of DABCO quaternized derivatives as innovative non-toxic delivery systems for hydrophobic drugs. Copyright © 2015 Elsevier B.V. All rights reserved.

Blood Cholesterol Measurement in Clinical Laboratories in the United States. Current Status. A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program.

ERIC Educational Resources Information Center

National Heart, Lung, and Blood Inst. (DHHS/NIH), Bethesda, MD.

Precise and accurate cholesterol measurements are required to identify and treat individuals with high blood cholesterol levels. However, the current state of reliability of blood cholesterol measurements suggests that considerable inaccuracy in cholesterol testing exists. This report describes the Laboratory Standardization Panel findings on the…

Antimicrobial Susceptibility Testing, Drug Resistance Mechanisms, and Therapy of Infections with Nontuberculous Mycobacteria

PubMed Central

Nash, Kevin A.; Wallace, Richard J.

2012-01-01

Summary: Within the past 10 years, treatment and diagnostic guidelines for nontuberculous mycobacteria have been recommended by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). Moreover, the Clinical and Laboratory Standards Institute (CLSI) has published and recently (in 2011) updated recommendations including suggested antimicrobial and susceptibility breakpoints. The CLSI has also recommended the broth microdilution method as the gold standard for laboratories performing antimicrobial susceptibility testing of nontuberculous mycobacteria. This article reviews the laboratory, diagnostic, and treatment guidelines together with established and probable drug resistance mechanisms of the nontuberculous mycobacteria. PMID:22763637

Measurement of Henry's Law Constants Using Internal Standards: A Quantitative GC Experiment for the Instrumental Analysis or Environmental Chemistry Laboratory

ERIC Educational Resources Information Center

Ji, Chang; Boisvert, Susanne M.; Arida, Ann-Marie C.; Day, Shannon E.

2008-01-01

An internal standard method applicable to undergraduate instrumental analysis or environmental chemistry laboratory has been designed and tested to determine the Henry's law constants for a series of alkyl nitriles. In this method, a mixture of the analytes and an internal standard is prepared and used to make a standard solution (organic solvent)…

[Accreditation of medical laboratories].

PubMed

Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar

2003-07-27

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the

Synthesis of amino-functionalized silica nanoparticles for preparation of new laboratory standards

NASA Astrophysics Data System (ADS)

Alvarez-Toral, Aitor; Fernández, Beatriz; Malherbe, Julien; Claverie, Fanny; Pecheyran, Christophe; Pereiro, Rosario

2017-12-01

Platinum group elements (PGEs) are particularly interesting analytes in different fields, including environmental samples as well as high cost materials that contain them, such as for example automotive catalysts. This type of solid samples could be analysed by laser ablation (LA) coupled to ICP-MS, which allow to significantly reducing the analysis time since the time-consuming processes for sample preparation are not required. There is a considerable demand of standards with high PGEs concentration for quantification purposes, which cannot be carried out easily using LA-ICP-MS because the available standards (i.e. NIST SRM 61 × series) do not have such analytes in the same concentration range. In this paper, a new strategy is proposed for the synthesis of homogeneous laboratory standards with Pt, Pd and Rh concentrations that range from 77 μg/g of Pd up to 2035 μg/g of Rh. The proposed strategy is based on the synthesis of monodisperse amino-functionalized amorphous silica nanoparticles, which can retain metal ions. In addition to Pt, Pd and Rh, three lanthanides were also added to the nanoparticles (La, Ce, Nd). Sturdy pressed pellets can be made from the resulting nanopowder without the use of any binder. Elemental composition of standards made of nanoparticles was analysed by conventional nebulization ICP-MS and their homogeneity was successfully evaluated by LA-ICP-MS.

Scale-up of recombinant cutinase recovery by whole broth extraction with PEG-phosphate aqueous two-phase.

PubMed

Costa, M J; Cunha, M T; Cabral, J M; Aires-Barros, M R

2000-01-01

A whole broth extraction using an aqueous two-phase system (ATPS) composed by 5% (w/w) PEG 3350 and 15% (w/w) phosphate was used for the scale-up extraction and isolation of a recombinant Fusarium solani pisi cutinase, an extracellular mutant enzyme expressed in Saccharomyces cerevisiae, containing a fusion peptide (WP)4. The experiments were carried out at three different scales (10 ml, 1 l and 30 l). Mixing time and stirrer speed were evaluated at lab scale (1 l) with two different system compositions. Stirrer speed between 400 and 800 rpm and mixing time between 2 and 5 min led to the highest recoveries of cutinase. In all cases, inclusive of pilot scale (30 l), the equilibrium was reached after a few minutes. The performance of ATPS was reproducible within the scale range of 0.010-30 l and provided a standard deviation of the yield lower than 8%, leading to (i) a partition coefficient over 50, (ii) a yield over 95% and (iii) a concentration factor over 5. The fusion of the peptide (WP)4 to the cutinase protein enabled a 400 increase of the partition coefficient relative to the wild-type strain.

[Modularization by the open standard. (II)].

PubMed

Muto, M; Takaha, Y; Chiba, N

2000-10-01

In recent years, accompanied by the marvelous development and spread of Laboratory Automation System(LAS), the NCCLS is now proposing five international standards for laboratory automation. We have based our laboratory on these "NCCLS standards of laboratory automation", we take these standards ahead first, and we now propose an open standard called "Open LA 21", to establish more detailed standard replacing the NCCLS laboratory automation standards.

Antimicrobial susceptibility testing of Mycobacterium tuberculosis complex for first and second line drugs by broth dilution in a microtiter plate format.

PubMed

Hall, Leslie; Jude, Kurt P; Clark, Shirley L; Wengenack, Nancy L

2011-06-24

The rapid detection of antimicrobial resistance is important in the effort to control the increase in resistant Mycobacterium tuberculosis (Mtb). Antimicrobial susceptibility testing (AST) of Mtb has traditionally been performed by the agar method of proportion or by macrobroth testing on an instrument such as the BACTEC (Becton Dickinson, Sparks, MD), VersaTREK (TREK Diagnostics, Cleveland, OH) or BacT/ALERT (bioMérieux, Hazelwood, MO). The agar proportion method, while considered the "gold" standard of AST, is labor intensive and requires calculation of resistance by performing colony counts on drug-containing agar as compared to drug-free agar. If there is ≥1% growth on the drug-containing medium as compared to drug-free medium, the organism is considered resistant to that drug. The macrobroth methods require instrumentation and test break point ("critical") drug concentrations for the first line drugs (isoniazid, ethambutol, rifampin, and pyrazinamide). The method described here is commercially available in a 96 well microtiter plate format [MYCOTB (TREK Diagnostics)] and contains increasing concentrations of 12 antimicrobials used for treatment of tuberculosis including both first (isoniazid, rifampin, ethambutol) and second line drugs (amikacin, cycloserine, ethionamide, kanamycin, moxifloxacin, ofloxacin, para-aminosalicylic acid, rifabutin, and streptomycin). Pyrazinamide, a first line drug, is not included in the microtiter plate due to its need for acidic test conditions. Advantages of the microtiter system include both ease of set up and faster turn around time (14 days) compared with traditional agar proportion (21 days). In addition, the plate can be set up from inoculum prepared using either broth or solid medium. Since the microtiter plate format is new and since Mtb presents unique safety challenges in the laboratory, this protocol will describe how to safely setup, incubate and read the microtiter plate.

75 FR 16813 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of [[Page 16814

Pre-treatment step with Leuconostoc mesenteroides or L. pseudomesenteroides strains removes furfural from Zymomonas mobilis ethanolic fermentation broth

USDA-ARS?s Scientific Manuscript database

Furfural (furan-2-carboxaldehyde), formed during dilute acid hydrolysis of biomass, is an inhibitor of growth and ethanol production by Zymomonas mobilis. The present study used a biological pre-treatment to reduce that amount of furfural in a model biofuel fermentation broth. The pre-treatment in...

Modeling the behavior of Listeria monocytogenes during enrichment in half Fraser broth; impact of pooling and the duration of enrichment on the detection of L. monocytogenes in food.

PubMed

Augustin, Jean-Christophe; Kalmokoff, Martin; Ells, Timothy; Favret, Sandra; Desreumaux, Jennifer; Decourseulles Brasseur, Emilie; Gnanou Besse, Nathalie

2016-12-01

A stochastic model describing the growth of Listeria monocytogenes during enrichment in half Fraser was developed for the purpose of estimating the effects of modifications to the first enrichment step of the EN ISO 11290-1 detection method. Information pertaining to the variability of growth rates, physiological state of the cell, and the behavior of individual cells contaminating the food were obtained from previously published studies. We used this model to investigate the impact of pooling enrichment broths (wet pooling) on the performance of the standard method. For validation of the model, the numbers of L. monocytogenes occurring in 88 naturally contaminated foods following pre-enrichment were compared to model-simulated microbial counts. The model was then used to perform simulations representative of the natural contamination observed for smoked salmon in the European baseline survey of 2010-2011. The model-estimated L. monocytogenes levels following individual enrichment or following the pooling of five broths where only one would be contaminated were compared. The model indicated a 10% loss of method sensitivity resulting from wet pooling. The model also predicted a 5% decrease in the sensitivity of the method when the duration of the enrichment was reduced from 24 to 22 h. Copyright © 2016 Elsevier Ltd. All rights reserved.

High pressure inactivation of Pseudomonas in black truffle - comparison with Pseudomonas fluorescens in tryptone soya broth

NASA Astrophysics Data System (ADS)

Ballestra, Patricia; Verret, Catherine; Cruz, Christian; Largeteau, Alain; Demazeau, Gerard; El Moueffak, Abdelhamid

2010-03-01

Pseudomonas is one of the most common genera in black Perigord truffle. Its inactivation by high pressure (100-500 MPa/10 min) applied on truffles at sub-zero or low temperatures was studied and compared with those of Pseudomonas fluorescens in tryptone soya broth. Pressurization of truffles at 300 MPa/4 °C reduced the bacterial count of Pseudomonas by 5.3 log cycles. Higher pressures of 400 or 500 MPa, at 4 °C or 20 °C, allowed us to slightly increase the level of destruction to the value of ca. 6.5 log cycles but did not permit us to completely inactivate Pseudomonas. The results showed a residual charge of about 10 CFU/g. Pressure-shift freezing of truffles, which consists in applying a pressure of 200 MPa/-18 °C for 10 min and then quickly releasing this pressure to induce freezing, reduced the population of Pseudomonas by 3.3 log cycles. The level of inactivation was higher than those obtained with conventional freezing. Endogenous Pseudomonas in truffle was shown to be more resistant to high pressure treatments than P. fluorescens used for inoculation of broths.

Functional magnetic mesoporous nanoparticles for efficient purification of laccase from fermentation broth in magnetically stabilized fluidized bed.

PubMed

Wang, Feng; Guo, Chen; Liu, Chun-Zhao

2013-12-01

A magnetically stabilized fluidized bed (MSFB) with the Cu(2+)-chelated magnetic mesoporous silica nanoparticles (MMSNPs-Cu(2+)) was established to purify laccase directly from the fermentation broth of Trametes versicolor. The MMSNPs-Cu(2+) particles in the MSFB maintained a stable bed expansion of two to threefold at a flow rate of 120-180 cm/h. At the optimal magnetic field intensity of 120 Gs, both the maximal Bodenstein number and the smallest axial dispersion coefficient were achieved, which resulted in a stable fluidization stage. The dynamic binding capacity of laccase in the MSFB decreased from 192.5 to144.3 mg/g when the flow velocity through the bed increased from 44.2 to 69.8 cm/h. The MSFB with MMSNPs-Cu(2+) achieved efficient laccase purification from the fermentation broth with 62.4-fold purification of laccase and 108.9 % activity yield. These results provided an excellent platform for the application of these magnetic mesoporous nanoparticles integrated with the MSFB in developing novel protein purification process.

Roles of laboratories and laboratory systems in effective tuberculosis programmes.

PubMed

Ridderhof, John C; van Deun, Armand; Kam, Kai Man; Narayanan, P R; Aziz, Mohamed Abdul

2007-05-01

Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB.

Antifungal Susceptibility Testing of Malassezia spp. with an Optimized Colorimetric Broth Microdilution Method.

PubMed

Leong, Cheryl; Buttafuoco, Antonino; Glatz, Martin; Bosshard, Philipp P

2017-06-01

Malassezia is a genus of lipid-dependent yeasts. It is associated with common skin diseases such as pityriasis versicolor and atopic dermatitis and can cause systemic infections in immunocompromised individuals. Owing to the slow growth and lipid requirements of these fastidious yeasts, convenient and reliable antifungal drug susceptibility testing assays for Malassezia spp. are not widely available. Therefore, we optimized a broth microdilution assay for the testing of Malassezia that is based on the CLSI and EUCAST assays for Candida and other yeasts. The addition of ingredients such as lipids and esculin provided a broth medium formulation that enabled the growth of all Malassezia spp. and could be read, with the colorimetric indicator resazurin, by visual and fluorescence readings. We tested the susceptibility of 52 strains of 13 Malassezia species to 11 commonly used antifungals. MIC values determined by visual readings were in good agreement with MIC values determined by fluorescence readings. The lowest MICs were found for the azoles itraconazole, posaconazole, and voriconazole, with MIC 90 values of 0.03 to 1.0 μg/ml, 0.06 to 0.5 μg/ml, and 0.03 to 2.0 μg/ml, respectively. All Malassezia spp. were resistant to echinocandins and griseofulvin. Some Malassezia spp. also showed high MIC values for ketoconazole, which is the most widely recommended topical antifungal to treat Malassezia skin infections. In summary, our assay enables the fast and reliable susceptibility testing of Malassezia spp. with a large panel of different antifungals. Copyright © 2017 American Society for Microbiology.

Antifungal Susceptibility Testing of Malassezia spp. with an Optimized Colorimetric Broth Microdilution Method

PubMed Central

Leong, Cheryl; Buttafuoco, Antonino

2017-01-01

ABSTRACT Malassezia is a genus of lipid-dependent yeasts. It is associated with common skin diseases such as pityriasis versicolor and atopic dermatitis and can cause systemic infections in immunocompromised individuals. Owing to the slow growth and lipid requirements of these fastidious yeasts, convenient and reliable antifungal drug susceptibility testing assays for Malassezia spp. are not widely available. Therefore, we optimized a broth microdilution assay for the testing of Malassezia that is based on the CLSI and EUCAST assays for Candida and other yeasts. The addition of ingredients such as lipids and esculin provided a broth medium formulation that enabled the growth of all Malassezia spp. and could be read, with the colorimetric indicator resazurin, by visual and fluorescence readings. We tested the susceptibility of 52 strains of 13 Malassezia species to 11 commonly used antifungals. MIC values determined by visual readings were in good agreement with MIC values determined by fluorescence readings. The lowest MICs were found for the azoles itraconazole, posaconazole, and voriconazole, with MIC90 values of 0.03 to 1.0 μg/ml, 0.06 to 0.5 μg/ml, and 0.03 to 2.0 μg/ml, respectively. All Malassezia spp. were resistant to echinocandins and griseofulvin. Some Malassezia spp. also showed high MIC values for ketoconazole, which is the most widely recommended topical antifungal to treat Malassezia skin infections. In summary, our assay enables the fast and reliable susceptibility testing of Malassezia spp. with a large panel of different antifungals. PMID:28381607

42 CFR 493.1445 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic... result is found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

77 FR 16551 - Standards for Private Laboratory Analytical Packages and Introduction to Laboratory Related...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... Food Modernization Safety Act for Private Laboratory Managers AGENCY: Food and Drug Administration, HHS... Food Modernization Safety Act for Private Laboratory Managers.'' The topic to be discussed is the...

Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays.

PubMed

Stepman, Hedwig C M; Tiikkainen, Ulla; Stöckl, Dietmar; Vesper, Hubert W; Edwards, Selvin H; Laitinen, Harri; Pelanti, Jonna; Thienpont, Linda M

2014-06-01

External quality assessment (EQA) with commutable samples is essential for assessing the quality of assays performed by laboratories, particularly when the emphasis is on their standardization status and interchangeability of results. We used a panel of 20 fresh-frozen single-donation serum samples to assess assays for the measurement of creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The commercial random access platforms included: Abbott Architect, Beckman Coulter AU, Ortho Vitros, Roche Cobas, Siemens Advia, and Thermo Scientific Konelab. The assessment was done at the peer group level and by comparison against the all-method trimmed mean or reference method values, where available. The considered quality indicators were intraassay imprecision, combined imprecision (including sample-matrix interference), bias, and total error. Fail/pass decisions were based on limits reflecting state-of-the-art performance, but also limits related to biological variation. Most assays showed excellent peer performance attributes, except for HDL- and LDL cholesterol. Cases in which individual assays had biases exceeding the used limits were the Siemens Advia creatinine (-4.2%), Ortho Vitros phosphate (8.9%), Beckman Coulter AU triglycerides (5.4%), and Thermo Scientific Konelab uric acid (6.4%), which lead to considerable interassay discrepancies. Additionally, large laboratory effects were observed that caused interlaboratory differences of >30%. The design of the EQA study was well suited for monitoring different quality attributes of assays performed in daily laboratory practice. There is a need for improvement, even for simple clinical chemistry analytes. In particular, the interchangeability of results remains jeopardized both by assay standardization issues and individual laboratory effects. © 2014 The American Association for Clinical Chemistry.

Inquiry-based laboratory investigations and student performance on standardized tests in biological science

NASA Astrophysics Data System (ADS)

Patke, Usha

Achievement data from the 3rd International Mathematics and Sciences Study and Program for International Student Assessment in science have indicated that Black students from economically disadvantaged families underachieve at alarming rates in comparison to White and economically advantaged peer groups. The study site was a predominately Black, urban school district experiencing underachievement. The purpose of this correlational study was to examine the relationship between students' use of inquiry-based laboratory investigations and their performance on the Biology End of Course Test, as well as to examine the relationship while partialling out the effects of student gender. Constructivist theory formed the theoretical foundation of the study. Students' perceived levels of experience with inquiry-based laboratory investigations were measured using the Laboratory Program Variable Inventory (LPVI) survey. LPVI scores of 256 students were correlated with test scores and were examined by student gender. The Pearson correlation coefficient revealed a small direct correlation between students' experience in inquiry-based laboratory investigation classes and standardized test scores on the Biology EOCT. A partial correlational analysis indicated that the correlation remained after controlling for gender. This study may prompt a change from teacher-centered to student-centered pedagogy at the local site in order to increase academic achievement for all students. The results of this study may also influence administrators and policy makers to initiate local, state, or nationwide curricular development. A change in curriculum may promote social change as students become more competent, and more able, to succeed in life beyond secondary school.

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

PubMed

Akyar, Işin

2009-10-01

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

Roles of laboratories and laboratory systems in effective tuberculosis programmes

PubMed Central

van Deun, Armand; Kam, Kai Man; Narayanan, PR; Aziz, Mohamed Abdul

2007-01-01

Abstract Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories’ functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB. PMID:17639219

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such... supervising non-waived laboratory testing; or (B) Beginning September 1, 1993, have at least 20 continuing... defined in § 493.1407; or (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such... supervising non-waived laboratory testing; or (B) Beginning September 1, 1993, have at least 20 continuing... defined in § 493.1407; or (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such... supervising non-waived laboratory testing; or (B) Beginning September 1, 1993, have at least 20 continuing... defined in § 493.1407; or (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section...

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

ERIC Educational Resources Information Center

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

[Laboratory accreditation and proficiency testing].

PubMed

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

[ISO 15189 medical laboratory accreditation].

PubMed

Aoyagi, Tsutomu

2004-10-01

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.

Dihydroberkleasmin A: a new eremophilane sesquiterpenoid from the fermentation broth of the plant endophytic fungus Pestalotiopsis photiniae.

PubMed

Yang, Xiao-Long; Zhang, Su; Zhu, Hua-Jie; Luo, Du-Qiang

2011-02-23

Dihydroberkleasmin A (1), a new ester-substituted sesquiterpenoid related to the eremophilane class, together with the known compound berkleasmin C (2), were isolated from the fermentation broth of the plant endophytic fungus Pestalotiopsis photiniae. The structure of dihydroberkleasmin A (1) was elucidated by extensive spectroscopic analysis. The stereochemistry was assigned by comparison of the NMR spectroscopic data with those of berkleasmin A.

Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

Cancer.gov

The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

Creep Laboratory manual

NASA Astrophysics Data System (ADS)

Osgerby, S.; Loveday, M. S.

1992-06-01

A manual for the NPL Creep Laboratory, a collective name given to two testing laboratories, the Uniaxial Creep Laboratory and the Advanced High Temperature Mechanical Testing Laboratory, is presented. The first laboratory is devoted to uniaxial creep testing and houses approximately 50 high sensitivity creep machines including 10 constant stress cam lever machines. The second laboratory houses a low cycle fatigue testing machine of 100 kN capacity driven by a servo-electric actuator, five machines for uniaxial tensile creep testing of engineering ceramics at temperatures up to 1600C, and an electronic creep machine. Details of the operational procedures for carrying out uniaxial creep testing are given. Calibration procedures to be followed in order to comply with the specifications laid down by British standards, and to provide traceability back to the primary standards are described.

Model-based design of a pilot-scale simulated moving bed for purification of citric acid from fermentation broth.

PubMed

Wu, Jinglan; Peng, Qijun; Arlt, Wolfgang; Minceva, Mirjana

2009-12-11

One of the conventional processes used for the recovery of citric acid from its fermentation broth is environmentally harmful and cost intensive. In this work an innovative benign process, which comprises simulated moving bed (SMB) technology and use of a tailor-made tertiary poly(4-vinylpyridine) (PVP) resin as a stationary phase is proposed. This paper focuses on a model-based design of the operation conditions for an existing pilot-scale SMB plant. The SMB unit is modeled on the basis of experimentally determined hydrodynamics, thermodynamics and mass transfer characteristics in a single chromatographic column. Three mathematical models are applied and validated for the prediction of the experimentally attained breakthrough and elution profiles of citric acid and the main impurity component (glucose). The transport dispersive model was selected for the SMB simulation and design studies, since it gives a satisfactory prediction of the elution profiles within acceptable computational time. The equivalent true moving bed (TMB) and SMB models give a good prediction of the experimentally attained SMB separation performances, obtained with a real clarified and concentrated fermentation broth as a feed mixture. The SMB separation requirements are set to at least 99.8% citric acid purity and 90% citric acid recovery in the extract stream. The complete regeneration in sections 1 and 4 is unnecessary. Therefore the net flow rates in all four SMB sections have been considered in the unit design. The influences of the operating conditions (the flow rate in each section, switching time and unit configuration) on the SMB performances were investigated systematically. The resulting SMB design provides 99.8% citric acid purity and 97.2% citric acid recovery in the extract. In addition the citric acid concentration in the extract is a half of its concentration in the pretreated fermentation broth (feed).

Standard metabolism and growth dynamics of laboratory-reared larvae of Sardina pilchardus.

PubMed

Moyano, M; Garrido, S; Teodósio, M A; Peck, M A

2014-04-01

This study provides the first measurements of the standard respiration rate (R(S)) and growth dynamics of European sardine Sardina pilchardus larvae reared in the laboratory. At 15° C, the relationship between RS (µl O(2) individual(-1)  h(-1)) and larval dry mass (M(D), µg) was equal to: R(S) = 0·0057(±0·0007, ± s.e.)·M(D) (0·8835(±0·0268)), (8-11% M(D) day(-1)). Interindividual differences in RS were not related to interindividual differences in growth rate or somatic (Fulton's condition factor) or biochemical-based condition (RNA:DNA). © 2014 The Fisheries Society of the British Isles.

Multivariate models for prediction of rheological characteristics of filamentous fermentation broth from the size distribution.

PubMed

Petersen, Nanna; Stocks, Stuart; Gernaey, Krist V

2008-05-01

The main purpose of this article is to demonstrate that principal component analysis (PCA) and partial least squares regression (PLSR) can be used to extract information from particle size distribution data and predict rheological properties. Samples from commercially relevant Aspergillus oryzae fermentations conducted in 550 L pilot scale tanks were characterized with respect to particle size distribution, biomass concentration, and rheological properties. The rheological properties were described using the Herschel-Bulkley model. Estimation of all three parameters in the Herschel-Bulkley model (yield stress (tau(y)), consistency index (K), and flow behavior index (n)) resulted in a large standard deviation of the parameter estimates. The flow behavior index was not found to be correlated with any of the other measured variables and previous studies have suggested a constant value of the flow behavior index in filamentous fermentations. It was therefore chosen to fix this parameter to the average value thereby decreasing the standard deviation of the estimates of the remaining rheological parameters significantly. Using a PLSR model, a reasonable prediction of apparent viscosity (micro(app)), yield stress (tau(y)), and consistency index (K), could be made from the size distributions, biomass concentration, and process information. This provides a predictive method with a high predictive power for the rheology of fermentation broth, and with the advantages over previous models that tau(y) and K can be predicted as well as micro(app). Validation on an independent test set yielded a root mean square error of 1.21 Pa for tau(y), 0.209 Pa s(n) for K, and 0.0288 Pa s for micro(app), corresponding to R(2) = 0.95, R(2) = 0.94, and R(2) = 0.95 respectively. Copyright 2007 Wiley Periodicals, Inc.

Validation of a Commercial Dry-Form Broth Microdilution Device (Sensititre) for Testing Tedizolid, a New Oxazolidinone

PubMed Central

Holliday, Nicole M.; Rhomberg, Paul R.

2014-01-01

Tedizolid, a novel oxazolidinone antibacterial with potent activity against a wide range of Gram-positive pathogens, was recently approved by regulatory authorities for the treatment of acute bacterial skin and skin structure infections. A commercial broth microdilution device (Sensititre; Thermo Fisher Scientific) was validated using 285 selected Gram-positive isolates, and the device was documented to have 100.0% essential and categorical agreement with reference MIC results and excellent MIC endpoint reproducibility. PMID:25411167

42 CFR 493.1355 - Condition: Laboratories performing PPM procedures; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing PPM procedures; laboratory director. 493.1355 Section 493.1355 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

42 CFR 493.1355 - Condition: Laboratories performing PPM procedures; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing PPM procedures; laboratory director. 493.1355 Section 493.1355 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

75 FR 62842 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-13

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.

PubMed

Michaud, Ginette Y

2005-01-01

In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.

Clinical laboratory accreditation in India.

PubMed

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

Harmonization of good laboratory practice requirements and laboratory accreditation programs.

PubMed

Royal, P D

1994-09-01

Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2012 CFR

2012-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2011 CFR

2011-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2014 CFR

2014-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2013 CFR

2013-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

75 FR 22150 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Correction In notice document 2010-7170 beginning on page 16813 in the issue of Friday, April 2...

From Topos to Oikos: The Standardization of Glass Containers as Epistemic Boundaries in Modern Laboratory Research (1850-1900).

PubMed

Espahangizi, Kijan

2015-09-01

Glass vessels such as flasks and test tubes play an ambiguous role in the historiography of modern laboratory research. In spite of the strong focus on the role of materiality in the last decades, the scientific glass vessel - while being symbolically omnipresent - has remained curiously neglected in regard to its materiality. The popular image or topos of the transparent, neutral, and quasi-immaterial glass container obstructs the view of the physico-chemical functionality of this constitutive inner boundary in modern laboratory environments and its material historicity. In order to understand how glass vessels were able to provide a stable epistemic containment of spatially enclosed experimental phenomena in the new laboratory ecologies emerging in the nineteenth and early twentieth century, I will focus on the history of the material standardization of laboratory glassware. I will follow the rise of a new awareness for measurement errors due to the chemical agency of experimental glass vessels, then I will sketch the emergence of a whole techno-scientific infrastructure for the improvement of glass container quality in late nineteenth-century Germany. In the last part of my argument, I will return to the laboratory by looking at the implementation of this glass reform that created a new oikos for the inner experimental milieus of modern laboratory research.

42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

Validation of a commercial dry-form broth microdilution device (Sensititre) for testing tedizolid, a new oxazolidinone.

PubMed

Jones, Ronald N; Holliday, Nicole M; Rhomberg, Paul R

2015-02-01

Tedizolid, a novel oxazolidinone antibacterial with potent activity against a wide range of Gram-positive pathogens, was recently approved by regulatory authorities for the treatment of acute bacterial skin and skin structure infections. A commercial broth microdilution device (Sensititre; Thermo Fisher Scientific) was validated using 285 selected Gram-positive isolates, and the device was documented to have 100.0% essential and categorical agreement with reference MIC results and excellent MIC endpoint reproducibility. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Competency assessment in laboratory medicine: Standardization and utility for technical staff assessment and recertification in Saudi Arabia.

PubMed

Nemenqani, Dalal M; Tekian, Ara; Park, Yoon Soo

2017-04-01

licensure in sample laboratories in Saudi Arabia. The program will be monitored and evaluated during and after implementation for processes and outcomes. Conclusions will be utilized for national competency program. This study represents an important step towards the implementation of a standardized laboratory competence assessment program at a national level.

Sweat test for cystic fibrosis: Wearable sweat sensor vs. standard laboratory test.

PubMed

Choi, Dong-Hoon; Thaxton, Abigail; Jeong, In Cheol; Kim, Kain; Sosnay, Patrick R; Cutting, Garry R; Searson, Peter C

2018-03-23

Sweat chloride testing for diagnosis of cystic fibrosis (CF) involves sweat induction, collection and handling, and measurement in an analytical lab. We have developed a wearable sensor with an integrated salt bridge for real-time measurement of sweat chloride concentration. Here, in a proof-of-concept study, we compare the performance of the sensor to current clinical practice in CF patients and healthy subjects. Sweat was induced on both forearms of 10 individuals with CF and 10 healthy subjects using pilocarpine iontophoresis. A Macroduct sweat collection device was attached to one arm and sweat was collected for 30 min and then sent for laboratory analysis. A sensor was attached to the other arm and the chloride ion concentration monitored in real time for 30 min using a Bluetooth transceiver and smart phone app. Stable sweat chloride measurements were obtained within 15 min following sweat induction using the wearable sensor. We define the detection time as the time at which the standard deviation of the real-time chloride ion concentration remained below 2 mEq/L for 5 min. The sweat volume for sensor measurements at the detection time was 13.1 ± 11.4 μL (SD), in many cases lower than the minimum sweat volume of 15 μL for conventional testing. The mean difference between sweat chloride concentrations measured by the sensor and the conventional laboratory practice was 6.2 ± 9.5 mEq/L (SD), close to the arm-to-arm variation of about 3 mEq/L. The Pearson correlation coefficient between the two measurements was 0.97 highlighting the excellent agreement between the two methods. A wearable sensor can be used to make real-time measurements of sweat chloride within 15 min following sweat induction, requiring a small sweat volume, and with excellent agreement to standard methods. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Radiation and Health Technology Laboratory Capabilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bihl, Donald E.; Lynch, Timothy P.; Murphy, Mark K.

2005-07-09

The Radiological Standards and Calibrations Laboratory, a part of Pacific Northwest National Laboratory (PNNL)(a) performs calibrations and upholds reference standards necessary to maintain traceability to national standards. The facility supports U.S. Department of Energy (DOE) programs at the Hanford Site, programs sponsored by DOE Headquarters and other federal agencies, radiological protection programs at other DOE and commercial nuclear sites and research and characterization programs sponsored through the commercial sector. The laboratory is located in the 318 Building of the Hanford Site's 300 Area. The facility contains five major exposure rooms and several laboratories used for exposure work preparation, low-activity instrumentmore » calibrations, instrument performance evaluations, instrument maintenance, instrument design and fabrication work, thermoluminescent and radiochromic Dosimetry, and calibration of measurement and test equipment (M&TE). The major exposure facilities are a low-scatter room used for neutron and photon exposures, a source well room used for high-volume instrument calibration work, an x-ray facility used for energy response studies, a high-exposure facility used for high-rate photon calibration work, a beta standards laboratory used for beta energy response studies and beta reference calibrations and M&TE laboratories. Calibrations are routinely performed for personnel dosimeters, health physics instrumentation, photon and neutron transfer standards alpha, beta, and gamma field sources used throughout the Hanford Site, and a wide variety of M&TE. This report describes the standards and calibrations laboratory.« less

A multi-pathogen selective enrichment broth for simultaneous growth of Salmonella enteria, Escherichia coli O157:H7 and Shigella flexneri

USDA-ARS?s Scientific Manuscript database

Salmonella, Shigella, and Escherichia coli O157:H7 contaminate similar types of food and all three can cause foodborne disease. Traditional microbiological enrichment broths to detect these pathogens are different in terms of their composition, which limits the application of multi-pathogen detectio...

Intercomparison of Laboratory Radiance Calibration Standards

NASA Technical Reports Server (NTRS)

Pavri, Betina; Chrien, Tom; Green, Robert; Williams, Orlesa

2000-01-01

Several standards for radiometric calibration were measured repeatedly with a spectroradiometer in order to understand how they compared in accuracy and stability. The tested radiance standards included a NIST 1000 W bulb and halon panel, two calibrated and stabilized integrating spheres, and a cavity blackbody. Results indicate good agreement between the blackbody and 1000 W bulb/spectralon panel, If these two radiance sources are assumed correct, then the integrating spheres did not conform. to their manufacturer-reported radiances in several regions of the spectrum. More detailed measurements am underway to investigate the discrepancy.

Inter-laboratory trial of a standardized sediment contact test with the aquatic plant Myriophyllum aquaticum (ISO 16191).

PubMed

Feiler, Ute; Ratte, Monika; Arts, Gertie; Bazin, Christine; Brauer, Frank; Casado, Carmen; Dören, Laszlo; Eklund, Britta; Gilberg, Daniel; Grote, Matthias; Gonsior, Guido; Hafner, Christoph; Kopf, Willi; Lemnitzer, Bernd; Liedtke, Anja; Matthias, Uwe; Okos, Ewa; Pandard, Pascal; Scheerbaum, Dirk; Schmitt-Jansen, Mechthild; Stewart, Kathleen; Teodorovic, Ivana; Wenzel, Andrea; Pluta, Hans-Jürgen

2014-03-01

A whole-sediment toxicity test with Myriophyllum aquaticum has been developed by the German Federal Institute of Hydrology and standardized within the International Organization for Standardization (ISO; ISO 16191). An international ring-test was performed to evaluate the precision of the test method. Four sediments (artificial, natural) were tested. Test duration was 10 d, and test endpoint was inhibition of growth rate (r) based on fresh weight data. Eighteen of 21 laboratories met the validity criterion of r ≥ 0.09 d(-1) in the control. Results from 4 tests that did not conform to test-performance criteria were excluded from statistical evaluation. The inter-laboratory variability of growth rates (20.6%-25.0%) and inhibition (26.6%-39.9%) was comparable with the variability of other standardized bioassays. The mean test-internal variability of the controls was low (7% [control], 9.7% [solvent control]), yielding a high discriminatory power of the given test design (median minimum detectable differences [MDD] 13% to 15%). To ensure these MDDs, an additional validity criterion of CV ≤ 15% of the growth rate in the controls was recommended. As a positive control, 90 mg 3,5-dichlorophenol/kg sediment dry mass was tested. The range of the expected growth inhibition was proposed to be 35 ± 15%. The ring test results demonstrated the reliability of the ISO 16191 toxicity test and its suitability as a tool to assess the toxicity of sediment and dredged material. © 2013 SETAC.

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

42 CFR 493.1234 - Standard: Communications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1234 Standard: Communications. The laboratory must have a system in place to... laboratory and an authorized person who orders or receives test results. [68 FR 3703, Jan. 24, 2003; 68 FR...

A professional development model for medical laboratory scientists working in the microbiology laboratory.

PubMed

Amerson, Megan H; Pulido, Lila; Garza, Melinda N; Ali, Faheem A; Greenhill, Brandy; Einspahr, Christopher L; Yarsa, Joseph; Sood, Pramilla K; Hu, Peter C

2012-01-01

The University of Texas M.D. Anderson Cancer Center, Division of Pathology and Laboratory Medicine is committed to providing the best pathology and medicine through: state-of-the art techniques, progressive ground-breaking research, education and training for the clinical diagnosis and research of cancer and related diseases. After surveying the laboratory staff and other hospital professionals, the Department administrators and Human Resource generalists developed a professional development model for Microbiology to support laboratory skills, behavior, certification, and continual education within its staff. This model sets high standards for the laboratory professionals to allow the labs to work at their fullest potential; it provides organization to training technologists based on complete laboratory needs instead of training technologists in individual areas in which more training is required if the laboratory needs them to work in other areas. This model is a working example for all microbiology based laboratories who want to set high standards and want their staff to be acknowledged for demonstrated excellence and professional development in the laboratory. The PDM model is designed to focus on the needs of the laboratory as well as the laboratory professionals.

Standard terminology in the laboratory and classroom

NASA Technical Reports Server (NTRS)

Strehlow, Richard A.

1992-01-01

Each of the materials produced by modern technologists is associated with a family of immaterials--all the concepts of substance, process, and purpose. It is concepts that are essential to transfer knowledge. It is concepts that are the stuff of terminology. Terminology is standardized today by companies, standards organizations, governments, and other groups. Simply described, it is the pre-negotiation of the meanings of terms. Terminology has become a key issue in businesses, and terminology knowledge is essential in understanding the modern world. The following is a introductory workshop discussing the concepts of terminology and methods of its standardization.

Modified ecometric technique (four-quadrant sequential streak) to evaluate Campylobacter enrichment broth proficiency in suppressing background microflora

USDA-ARS?s Scientific Manuscript database

Ecometric technique is a semi-quantitative scoring method used for quality control of culture media in microbiological laboratories. The technique involves inoculation with defined populations of specific culture onto solid media via a standardized chronological streaking technique, leading to ever-...

[Detection of Huperzine A and Huperzine B in fermentation broth of endophytic fungus Colletotrichum gloesporioides from Huperzia serrate by HPLC].

PubMed

Hu, Liqin; Kang, Xincong; Shen, Pengyuan; Chen, Tian; Zhang, Jiayin; Liu, Dongbo

2018-05-25

In this study, we established a rapid and efficient HPLC method to determine the accumulation of Huperzine A and Huperzine B in the fermentation broth of endophytic fungus Colletotrichum gloesporioides from Huperzia serrate. The chloroform extracts of fermentation broth were dissolved in methanol and filtered before injection for HPLC analysis. The analysis was performed on an Agilent Eclipse plus-C18 column (250 mm×4.6 mm, 5 μm) by isocratic elution. The mobile phase was 0.015 mol/L ammonium acetate-methanol (70:30, V/V), the flow rate was 1 mL/min and the detection wavelength was set at 308 nm. Huperzine A and Huperzine B could be well separated within 25 min. Good linearity of Huperzine A was found in the range of 1.50-48.00 μg/mL (r=0.999 5), and that of huperzine B was in 0.25-7.50 μg/mL (r=0.999 7). The average recoveries of Huperzine A and Huperzine B were 106.83% and 108.06%, respectively (RSD=3.34%, 3.60%). The results demonstrate that this method can detect the content of huperzine A and huperzine B in fermentation broth simply, rapidly, accurately and in good reproducibility. Under the optimized conditions, the accumulated content of huperzine A and huperzine B were measured from the sixth to the fifteenth day. Huperzine A and Huperzine B reached the highest (12.417 0 μg/mL and 4.660 3 μg/mL, respectively) at the fourteenth and eighth days. The analysis methodology could contribute to the future study of huperzine A and huperzine B biosynthesis in C. gloeosporioides, consequently facilitate the development of new drug resources.

Comparison of Minocycline Susceptibility Testing Methods for Carbapenem-Resistant Acinetobacter baumannii.

PubMed

Wang, Peng; Bowler, Sarah L; Kantz, Serena F; Mettus, Roberta T; Guo, Yan; McElheny, Christi L; Doi, Yohei

2016-12-01

Treatment options for infections due to carbapenem-resistant Acinetobacter baumannii are extremely limited. Minocycline is a semisynthetic tetracycline derivative with activity against this pathogen. This study compared susceptibility testing methods that are used in clinical microbiology laboratories (Etest, disk diffusion, and Sensititre broth microdilution methods) for testing of minocycline, tigecycline, and doxycycline against 107 carbapenem-resistant A. baumannii clinical isolates. Susceptibility rates determined with the standard broth microdilution method using cation-adjusted Mueller-Hinton (MH) broth were 77.6% for minocycline and 29% for doxycycline, and 92.5% of isolates had tigecycline MICs of ≤2 μg/ml. Using MH agar from BD and Oxoid, susceptibility rates determined with the Etest method were 67.3% and 52.3% for minocycline, 21.5% and 18.7% for doxycycline, and 71% and 29.9% for tigecycline, respectively. With the disk diffusion method using MH agar from BD and Oxoid, susceptibility rates were 82.2% and 72.9% for minocycline and 34.6% and 34.6% for doxycycline, respectively, and rates of MICs of ≤2 μg/ml were 46.7% and 23.4% for tigecycline. In comparison with the standard broth microdilution results, very major rates were low (∼2.8%) for all three drugs across the methods, but major error rates were higher (∼5.6%), especially with the Etest method. For minocycline, minor error rates ranged from 14% to 37.4%. For tigecycline, minor error rates ranged from 6.5% to 69.2%. The majority of minor errors were due to susceptible results being reported as intermediate. For minocycline susceptibility testing of carbapenem-resistant A. baumannii strains, very major errors are rare, but major and minor errors overcalling strains as intermediate or resistant occur frequently with susceptibility testing methods that are feasible in clinical laboratories. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Internal audit in a microbiology laboratory.

PubMed Central

Mifsud, A J; Shafi, M S

1995-01-01

AIM--To set up a programme of internal laboratory audit in a medical microbiology laboratory. METHODS--A model of laboratory based process audit is described. Laboratory activities were examined in turn by specimen type. Standards were set using laboratory standard operating procedures; practice was observed using a purpose designed questionnaire and the data were analysed by computer; performance was assessed at laboratory audit meetings; and the audit circle was closed by re-auditing topics after an interval. RESULTS--Improvements in performance scores (objective measures) and in staff morale (subjective impression) were observed. CONCLUSIONS--This model of process audit could be applied, with amendments to take local practice into account, in any microbiology laboratory. PMID:7665701

Diagnostic accuracy of the InBiOS AMD rapid diagnostic test for the detection of Burkholderia pseudomallei antigen in grown blood culture broth.

PubMed

Peeters, Marjan; Chung, Panha; Lin, Hua; Mortelmans, Kristien; Phe, Chhundy; San, Chentha; Kuijpers, Laura Maria Francisca; Teav, Syna; Phe, Thong; Jacobs, Jan

2018-06-01

To assess the diagnostic and operational performance of the InBiOS AMD rapid diagnostic test (RDT) (Seattle, USA) for the detection of B. pseudomallei in grown blood culture broth. The InBiOS RDT is a lateral flow immunoassay in a strip format detecting B. pseudomallei capsular polysaccharide in culture fluids, marketed for research only. Broth of blood culture bottles (BacT/Alert, bioMérieux, Marcy L'Etoile, France) sampled in adult patients at the Sihanouk Hospital Center of HOPE, Phnom Penh, Cambodia, during 2010-2017 and stored at - 80 °C was tested. They included samples grown with B. pseudomallei (n = 114), samples with no growth (n = 12), and samples with growth of other pathogens (n = 139, among which Burkholderia cepacia (n = 5)). Diagnostic sensitivity and specificity were 96.5% [95% confidence interval (CI): 91.3-98.6%] and 100% [CI: 97.5-100%] respectively. Background clearance and line intensities were good and very good. The RDT's test strip, not housed in a cassette, caused difficulties in manipulation and biosafety. The centrifugation step prescribed by the procedure challenged biosafety, but processing of 19 B. pseudomallei samples without centrifugation showed similar results for line intensity and background clearance, compared to centrifugation. The InBiOS RDT showed excellent accuracy for detection of B. pseudomallei in grown blood culture broth. Provided operational adaptations such as cassette housing, it has the potential to reduce time to diagnosis of melioidosis.

A colorimetric broth microdilution method for assessment of Helicobacter pylori sensitivity to antimicrobial agents.

PubMed

Knezevic, Petar; Aleksic Sabo, Verica; Simin, Natasa; Lesjak, Marija; Mimica-Dukic, Neda

2018-04-15

Helicobacter pylori is a major infective etiological agent of the upper gastrointestinal tract diseases. The bacterium exhibits resistance to various conventional antibiotics, being usually challenging for eradication. Since there is an urge to consider alternative therapeutic strategies, the aim of the study was to examine selected essential oils of plants belonging to families Cupressaceae (Juniperus communis) and Lamiaceae (Hyssopus officinalis, Salvia officinalis, Melissa officinalis, Lavandula angustifolia, Ocimum basilicum and Thymus serpyllum) against H. pylori, using an improved microdilution broth method. The oils were examined in concentration range from 0.03 to 4 μL/mL. The method comprises Brain-heart infusion broth supplemented with yeast extract, horse serum and IsoVitaleX. After 3 day incubation, an equal volume of double strengthen Christensen's urea was added into each well and incubated for additional 4 h. In wells with present H. pylori, the medium changed color from yellow to purple, allowing MIC determination even without a microtitre plate reader. The microtitre format method is convenient as it is less expensive, easier to perform and requires less amount of an anti-H. pylori agent. The improved method enhances specificity to H. pylori, as fast urease activity is almost an exclusive property of this bacterium. The application of the second step incubation with Christensen's urea decreases the possibility of false positive/negative results due to contaminant growth or commonly poor H. pylori growth. Among the examined oils, J. communis, H. officinalis and O. basilicum were not active with the highest applied concentrations, while the most active was T. serpyllum, with MIC 2.0-4.0 μL/mL. This is the first report on essential oils activity of T. serpyllum and H. officinalis against H. pylori. Copyright © 2018 Elsevier B.V. All rights reserved.

External Standards or Standard Addition? Selecting and Validating a Method of Standardization

NASA Astrophysics Data System (ADS)

Harvey, David T.

2002-05-01

A common feature of many problem-based laboratories in analytical chemistry is a lengthy independent project involving the analysis of "real-world" samples. Students research the literature, adapting and developing a method suitable for their analyte, sample matrix, and problem scenario. Because these projects encompass the complete analytical process, students must consider issues such as obtaining a representative sample, selecting a method of analysis, developing a suitable standardization, validating results, and implementing appropriate quality assessment/quality control practices. Most textbooks and monographs suitable for an undergraduate course in analytical chemistry, however, provide only limited coverage of these important topics. The need for short laboratory experiments emphasizing important facets of method development, such as selecting a method of standardization, is evident. The experiment reported here, which is suitable for an introductory course in analytical chemistry, illustrates the importance of matrix effects when selecting a method of standardization. Students also learn how a spike recovery is used to validate an analytical method, and obtain a practical experience in the difference between performing an external standardization and a standard addition.

42 CFR 493.1233 - Standard: Complaint investigations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1233 Standard: Complaint investigations. The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory...

Design and verification of the shielding around the new Neutron Standards Laboratory (LPN) at CIEMAT.

PubMed

Méndez-Villafañe, R; Guerrero, J E; Embid, M; Fernández, R; Grandio, R; Pérez-Cejuela, P; Márquez, J L; Alvarez, F; Ortego, P

2014-10-01

The construction of the new Neutron Standards Laboratory at CIEMAT (Laboratorio de Patrones Neutrónicos) has been finalised and is ready to provide service. The facility is an ∼8 m×8 m×8 m irradiation vault, following the International Organization for Standardization 8529 recommendations. It relies on several neutron sources: a 5-GBq (5.8× 10(8) s(-1)) (252)Cf source and two (241)Am-Be neutron sources (185 and 11.1 GBq). The irradiation point is located 4 m over the ground level and in the geometrical centre of the room. Each neutron source can be moved remotely from its storage position inside a water pool to the irradiation point. Prior to this, an important task to design the neutron shielding and to choose the most appropriate materials has been developed by the Radiological Security Unit and the Ionizing Radiations Metrology Laboratory. MCNPX was chosen to simulate the irradiation facility. With this information the walls were built with a thickness of 125 cm. Special attention was put on the weak points (main door, air conditioning system, etc.) so that the ambient dose outside the facility was below the regulatory limits. Finally, the Radiation Protection Unit carried out a set of measurements in specific points around the installation with an LB6411 neutron monitor and a Reuter-Stokes high-pressure ion chamber to verify experimentally the results of the simulation. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

PubMed Central

Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

2012-01-01

Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

42 CFR 493.1850 - Laboratory registry.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratory registry. 493.1850 Section 493.1850... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1850 Laboratory... laboratories, including the following: (1) A list of laboratories that have been convicted, under Federal or...

42 CFR 493.1850 - Laboratory registry.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratory registry. 493.1850 Section 493.1850... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1850 Laboratory... laboratories, including the following: (1) A list of laboratories that have been convicted, under Federal or...

42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

Preservice laboratory education strengthening enhances sustainable laboratory workforce in Ethiopia

PubMed Central

2013-01-01

Background There is a severe healthcare workforce shortage in sub Saharan Africa, which threatens achieving the Millennium Development Goals and attaining an AIDS-free generation. The strength of a healthcare system depends on the skills, competencies, values and availability of its workforce. A well-trained and competent laboratory technologist ensures accurate and reliable results for use in prevention, diagnosis, care and treatment of diseases. Methods An assessment of existing preservice education of five medical laboratory schools, followed by remedial intervention and monitoring was conducted. The remedial interventions included 1) standardizing curriculum and implementation; 2) training faculty staff on pedagogical methods and quality management systems; 3) providing teaching materials; and 4) procuring equipment for teaching laboratories to provide practical skills to complement didactic education. Results A total of 2,230 undergraduate students from the five universities benefitted from the standardized curriculum. University of Gondar accounted for 252 of 2,230 (11.3%) of the students, Addis Ababa University for 663 (29.7%), Jimma University for 649 (29.1%), Haramaya University for 429 (19.2%) and Hawassa University for 237 (10.6%) of the students. Together the universities graduated 388 and 312 laboratory technologists in 2010/2011 and 2011/2012 academic year, respectively. Practical hands-on training and experience with well-equipped laboratories enhanced and ensured skilled, confident and competent laboratory technologists upon graduation. Conclusions Strengthening preservice laboratory education is feasible in resource-limited settings, and emphasizing its merits (ample local capacity, country ownership and sustainability) provides a valuable source of competent laboratory technologists to relieve an overstretched healthcare system. PMID:24164781

Commercial Lysogeny Broth culture media and oxidative stress: a cautious tale.

PubMed

Ezraty, Benjamin; Henry, Camille; Hérisse, Marion; Denamur, Erick; Barras, Frédéric

2014-09-01

Lysogeny Broth (LB), most often misnamed Luria-Bertani medium, ranks among the most commonly used growth media in microbiology. Surprisingly, we observed that oxidative levels vary with the commercial origin of the LB ready to use powder. Indeed, growth on solid media of Escherichia coli and Salmonella derivatives lacking antioxidative stress defenses, such as oxyR mutant devoid of the H2O2-sensing transcriptional activator or Hpx(-) strains lacking catalases and peroxidases, exhibit different phenotypes on LB-Sigma or LB-Difco. Using gene fusion and exogenously added catalase, we found that LB-Sigma contains higher levels of H2O2 than LB-Difco. Also we observed differences in population counts of 82 clinical and environmental isolates of E. coli, depending on the LB used. Further investigations revealed a significant influence of the commercial origin of agar as well. Besides being a warning to the wide population of LB users, our observations provide researchers in the oxidative stress field with a tool to appreciate the severity of mutations in antioxidative stress defenses. Copyright © 2014 Elsevier Inc. All rights reserved.

Rapid Identification of Bacteria in Positive Blood Culture Broths by Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry▿

PubMed Central

Stevenson, Lindsay G.; Drake, Steven K.; Murray, Patrick R.

2010-01-01

Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry is a rapid, accurate method for identifying bacteria and fungi recovered on agar culture media. We report herein a method for the direct identification of bacteria in positive blood culture broths by MALDI-TOF mass spectrometry. A total of 212 positive cultures were examined, representing 32 genera and 60 species or groups. The identification of bacterial isolates by MALDI-TOF mass spectrometry was compared with biochemical testing, and discrepancies were resolved by gene sequencing. No identification (spectral score of <1.7) was obtained for 42 (19.8%) of the isolates, due most commonly to insufficient numbers of bacteria in the blood culture broth. Of the bacteria with a spectral score of ≥1.7, 162 (95.3%) of 170 isolates were correctly identified. All 8 isolates of Streptococcus mitis were misidentified as being Streptococcus pneumoniae isolates. This method provides a rapid, accurate, definitive identification of bacteria within 1 h of detection in positive blood cultures with the caveat that the identification of S. pneumoniae would have to be confirmed by an alternative test. PMID:19955282

Rapid identification of bacteria in positive blood culture broths by matrix-assisted laser desorption ionization-time of flight mass spectrometry.

PubMed

Stevenson, Lindsay G; Drake, Steven K; Murray, Patrick R

2010-02-01

Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry is a rapid, accurate method for identifying bacteria and fungi recovered on agar culture media. We report herein a method for the direct identification of bacteria in positive blood culture broths by MALDI-TOF mass spectrometry. A total of 212 positive cultures were examined, representing 32 genera and 60 species or groups. The identification of bacterial isolates by MALDI-TOF mass spectrometry was compared with biochemical testing, and discrepancies were resolved by gene sequencing. No identification (spectral score of < 1.7) was obtained for 42 (19.8%) of the isolates, due most commonly to insufficient numbers of bacteria in the blood culture broth. Of the bacteria with a spectral score of > or = 1.7, 162 (95.3%) of 170 isolates were correctly identified. All 8 isolates of Streptococcus mitis were misidentified as being Streptococcus pneumoniae isolates. This method provides a rapid, accurate, definitive identification of bacteria within 1 h of detection in positive blood cultures with the caveat that the identification of S. pneumoniae would have to be confirmed by an alternative test.

42 CFR 493.1101 - Standard: Facilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Facilities. 493.1101 Section 493.1101... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Facility Administration for Nonwaived Testing § 493.1101 Standard: Facilities. (a) The laboratory must be constructed, arranged, and maintained to...

Exposure to hazardous substances in a standard molecular biology laboratory environment: evaluation of exposures in IARC laboratories.

PubMed

Chapot, Brigitte; Secretan, Béatrice; Robert, Annie; Hainaut, Pierre

2009-07-01

Working in a molecular biology laboratory environment implies regular exposure to a wide range of hazardous substances. Several recent studies have shown that laboratory workers may have an elevated risk of certain cancers. Data on the nature and frequency of exposures in such settings are scanty. The frequency of use of 163 agents by staff working in molecular biology laboratories was evaluated over a period of 4 years by self-administered questionnaire. Of the agents listed, ethanol was used by the largest proportion of staff (70%), followed by ethidium bromide (55%). Individual patterns of use showed three patterns, namely (i) frequent use of a narrow range of products, (ii) occasional use of a wide range of products, and (iii) frequent and occasional use of an intermediate range of products. Among known or suspected carcinogens (International Agency for Research on Cancer Group 1 and 2A, respectively), those most frequently used included formaldehyde (17%), oncogenic viruses (4%), and acrylamide (32%). The type of exposure encountered in research laboratories is extremely diverse. Few carcinogenic agents are used frequently but many laboratory workers may be exposed occasionally to known human carcinogens. In addition, many of the chemicals handled by staff represent a health hazard. The results enabled the staff physician to develop an individual approach to medical surveillance and to draw a personal history of occupational exposures for laboratory staff.

Procedures of Exercise Physiology Laboratories

NASA Technical Reports Server (NTRS)

Bishop, Phillip A.; Fortney, Suzanne; Greenisen, Michael; Siconolfi, Steven F.; Bamman, Marcas M.; Moore, Alan D., Jr.; Squires, William

1998-01-01

This manual describes the laboratory methods used to collect flight crew physiological performance data at the Johnson Space Center. The Exercise Countermeasures Project Laboratory is a standard physiology laboratory; only the application to the study of human physiological adaptations to spaceflight is unique. In the absence of any other recently published laboratory manual, this manual should be a useful document staffs and students of other laboratories.

Production of laccase by Coriolus versicolor and its application in decolorization of dyestuffs: (II). Decolorization of dyes by laccase containing fermentation broth with or without self-immobilized mycelia.

PubMed

Lin, Jian-Ping; Lian, Wei; Xia, Li-Ming; Cen, Pei-Lin

2003-01-01

The capability of decolorization for commercial dyes by Coriolus versicolor fermentation broth containing laccase with or without immobilized mycelium was evaluated. With cell-free fermentation broth containing laccase, high decolorization ratio was achieved foracid orange 7, but not for the other dyes concerned. The immobilized mycelium was proved to be more efficient than the cell-free system. All the four dyestuffs studied were found being decolourized with certain extent by immobilized mycelium. The repeated-batch decolorization was carried out with satisfactory results. The experimental data showed that the continuous decolorization of wastewater from a printing and dyeing industry was possible by using the self-immobilized C. versicolor.

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.

PubMed

Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome

2015-01-15

Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality

42 CFR 493.645 - Additional fee(s) applicable to approved State laboratory programs and laboratories issued a...

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.645 Additional fee(s) applicable to approved State laboratory programs and... laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or...

Effect of Sex on Flavor-related and Functional Compounds in Freeze-dried Broth Made from Korean Native Chicken

PubMed Central

Jayasena, Dinesh D.; Jung, Samooel; Alahakoon, Amali U.; Nam, Ki Chang

2014-01-01

Studies on the flavour characteristics of meat-based broth, quantification of flavour-related and functional compounds, and factors affecting the availability of such compounds are minimal. The present study was designed to determine the effects of sex on flavor-related and functional compounds in freeze-dried broth (FDB) made from Korean native chickens (KNC). Male and female KNC from a commercial strain (WoorimatdagTM) were reared under similar commercial conditions. FDB was separately prepared using male and female birds aged 100 d (six birds of each sex) and analyzed for nucleotide, free amino acid, betaine, carnitine, carnosine, anserine, and creatine contents, and fatty acid composition. The levels of betaine, carnitine and creatine in FDB were not significantly different between the two sexes (p>0.05) in KNC. Carnosine and anserine were not detected in FDB samples. However, FDB from female chickens had significantly higher inosine-5-monophosphate and arachidonic acid contents than did FDB from male chickens. FDB prepared with male KNC contained higher levels of inosine, linoleic acid, glycine, alanine, lysine, and serine (p<0.05). However, glutamic acid, oleic acid, and DHA were present in comparable amounts (p>0.05) in FDB made from male and female KNC. Our findings suggest that the sex of KNC has significant effect on the contents of flavor-related compounds, but not functional compounds. PMID:26761282

Proficiency Testing as a tool to monitor consistency of measurements in the IAEA/WHO Network of Secondary Standards Dosimetry Laboratories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meghzifene, Ahmed; Czap, Ladislav; Shortt, Ken

2008-08-14

The International Atomic Energy Agency (IAEA) and the World Health Organization (WHO) established a Network of Secondary Standards Dosimetry Laboratories (IAEA/WHO SSDL Network) in 1976. Through SSDLs designated by Member States, the Network provides a direct link of national dosimetry standards to the international measurement system of standards traceable to the Bureau International des Poids et Mesures (BIPM). Within this structure and through the proper calibration of field instruments, the SSDLs disseminate S.I. quantities and units.To ensure that the services provided by SSDL members to end-users follow internationally accepted standards, the IAEA has set up two different comparison programmes. Onemore » programme relies on the IAEA/WHO postal TLD service and the other uses comparisons of calibrated ionization chambers to help the SSDLs verify the integrity of their national standards and the procedures used for the transfer of the standards to the end-users. The IAEA comparisons include {sup 60}Co air kerma (N{sub K}) and absorbed dose to water (N{sub D,W}) coefficients. The results of the comparisons are confidential and are communicated only to the participants. This is to encourage participation of the laboratories and their full cooperation in the reconciliation of any discrepancy.This work describes the results of the IAEA programme comparing calibration coefficients for radiotherapy dosimetry, using ionization chambers. In this programme, ionization chambers that belong to the SSDLs are calibrated sequentially at the SSDL, at the IAEA, and again at the SSDL. As part of its own quality assurance programme, the IAEA has participated in several regional comparisons organized by Regional Metrology Organizations.The results of the IAEA comparison programme show that the majority of SSDLs are capable of providing calibrations that fall inside the acceptance level of 1.5% compared to the IAEA.« less

Multicenter Comparative Evaluation of Six Commercial Systems and the National Committee for Clinical Laboratory Standards M27-A Broth Microdilution Method for Fluconazole Susceptibility Testing of Candida Species

PubMed Central

Morace, G.; Amato, G.; Bistoni, F.; Fadda, G.; Marone, P.; Montagna, M. T.; Oliveri, S.; Polonelli, L.; Rigoli, R.; Mancuso, I.; La Face, S.; Masucci, L.; Romano, L.; Napoli, C.; Tatò, D.; Buscema, M. G.; Belli, C. M. C.; Piccirillo, M. M.; Conti, S.; Covan, S.; Fanti, F.; Cavanna, C.; D'Alò, F.; Pitzurra, L.

2002-01-01

Fluconazole susceptibility among 800 clinical Candida isolates (60% C. albicans) and two control strains (C. krusei ATCC 6258 and C. parapsilosis ATCC 22019) was tested with the NCCLS M27-A method (gold standard) and six commercial products (Candifast, disk, Etest, Fungitest, Integral System Yeasts, and Sensititre YeastOne). Results were classified as susceptible, susceptible-dose dependent, or resistant using M27-A breakpoints or, for Fungitest, Integral System Yeasts, and Candifast, as susceptible, intermediate, or resistant, according to the manufacturers' instructions. Concordance with NCCLS M27-A results was analyzed with the χ2 test. Intra- and interlaboratory reproducibility was also evaluated. NCCLS M27-A (90.1%), Etest (93.1%), Sensititre YeastOne (93.1%), disk (96.7%), Fungitest (92.6%), Integral System Yeasts (40.6%), and Candifast (6.0%) classified the indicated percentages of C. albicans isolates as susceptible. Among non-C. albicans strains, the percentages of susceptible isolates were as follows: NCCLS M27-A, 74.0%; Etest, 83.8%; Sensititre YeastOne, 64.1%; disk, 60.6%; Fungitest, 76.6%; Integral System Yeasts, 28.3%; and Candifast, 27.4%. All methods except Candifast and Integral System Yeasts showed good agreement with NCCLS M27-A results for both C albicans and non-C. albicans isolates. Intralaboratory reproducibility was excellent for NCCLS M27-A, Etest, Sensititre YeastOne, disk, and Fungitest (88 to 91%). Similar results emerged from the interlaboratory reproducibility evaluation. Our findings indicate that some commercial methods can be useful for fluconazole susceptibility testing of clinical Candida isolates. Those characterized by a lack of medium standardization and/or objective interpretative criteria should be avoided. Particular caution is necessary when testing is being done for clinical and epidemiological purposes. PMID:12149358

Comparison of a New Cobinamide-Based Method to a Standard Laboratory Method for Measuring Cyanide in Human Blood

PubMed Central

Swezey, Robert; Shinn, Walter; Green, Carol; Drover, David R.; Hammer, Gregory B.; Schulman, Scott R.; Zajicek, Anne; Jett, David A.; Boss, Gerry R.

2013-01-01

Most hospital laboratories do not measure blood cyanide concentrations, and samples must be sent to reference laboratories. A simple method is needed for measuring cyanide in hospitals. The authors previously developed a method to quantify cyanide based on the high binding affinity of the vitamin B12 analog, cobinamide, for cyanide and a major spectral change observed for cyanide-bound cobinamide. This method is now validated in human blood, and the findings include a mean inter-assay accuracy of 99.1%, precision of 8.75% and a lower limit of quantification of 3.27 µM cyanide. The method was applied to blood samples from children treated with sodium nitroprusside and it yielded measurable results in 88 of 172 samples (51%), whereas the reference laboratory yielded results in only 19 samples (11%). In all 19 samples, the cobinamide-based method also yielded measurable results. The two methods showed reasonable agreement when analyzed by linear regression, but not when analyzed by a standard error of the estimate or paired t-test. Differences in results between the two methods may be because samples were assayed at different times on different sample types. The cobinamide-based method is applicable to human blood, and can be used in hospital laboratories and emergency rooms. PMID:23653045

Preservation Study for Ultra-Dilute VX Standards | Science ...

EPA Pesticide Factsheets

Report Lawrence Livermore National Laboratory (LLNL) supplies ultra-dilute (10 µg/mL) chemical warfare agent (CWA) standards to the Environmental Response Laboratory Network (ERLN) laboratories to allow the use of authentic standards to assist in analyses required for a remediation event involving CWAs. For this reason, it is important to collect data regarding the shelf-lives of these standards. The instability has the potential to impact quality control in regional ERLN laboratories, resulting in data that are difficult to interpret. Thus, this study investigated the use of chemical stabilizers to increase the shelf-life of VX standards. VX standards with long shelf-lives are desirable, as long shelf-life would significantly reduce the costs associated with synthesizing and resupplying the ERLN laboratories with VX.

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laboratories

PubMed Central

2011-01-01

Background There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval. Methods Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology. Results Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory. Conclusions In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods. PMID:21477356

Isolation gowns in health care settings: Laboratory studies, regulations and standards, and potential barriers of gown selection and use

PubMed Central

Kilinc Balci, F. Selcen

2016-01-01

Although they play an important role in infection prevention and control, textile materials and personal protective equipment (PPE) used in health care settings are known to be one of the sources of cross-infection. Gowns are recommended to prevent transmission of infectious diseases in certain settings; however, laboratory and field studies have produced mixed results of their efficacy. PPE used in health care is regulated as either class I (low risk) or class II (intermediate risk) devices in the United States. Many organizations have published guidelines for the use of PPE, including isolation gowns, in health care settings. In addition, the Association for the Advancement of Medical Instrumentation published a guidance document on the selection of gowns and a classification standard on liquid barrier performance for both surgical and isolation gowns. However, there is currently no existing standard specific to isolation gowns that considers not only the barrier resistance but also a wide array of end user desired attributes. As a result, infection preventionists and purchasing agents face several difficulties in the selection process, and end users have limited or no information on the levels of protection provided by isolation gowns. Lack of knowledge about the performance of protective clothing used in health care became more apparent during the 2014 Ebola epidemic. This article reviews laboratory studies, regulations, guidelines and standards pertaining to isolation gowns, characterization problems, and other potential barriers of isolation gown selection and use. PMID:26391468

International Organization for Standardization (ISO) 15189.

PubMed

Schneider, Frank; Maurer, Caroline; Friedberg, Richard C

2017-09-01

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. © The Korean Society for Laboratory Medicine.

A four-quadrant sequential streak technique to evaluate Campylobacter selective broths for suppressing background flora in broiler carcass rinses

USDA-ARS?s Scientific Manuscript database

The ecometric technique is a semi-quantitative scoring method used in the quality control of culture media in microbiology laboratories. This technique involves inoculation with defined populations of a specific culture onto solid media via a standardized chronological streaking technique, leading ...

Interlaboratory Study of Quality Control Isolates for a Broth Microdilution Method (Modified CLSI M38-A) for Testing Susceptibilities of Dermatophytes to Antifungals▿

PubMed Central

Ghannoum, M. A.; Arthington-Skaggs, B.; Chaturvedi, V.; Espinel-Ingroff, A.; Pfaller, M. A.; Rennie, R.; Rinaldi, M. G.; Walsh, T. J.

2006-01-01

The Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards, or NCCLS) M38-A standard for the susceptibility testing of filamentous fungi does not specifically address the testing of dermatophytes. In 2003, a multicenter study investigated the reproducibility of the microdilution method developed at the Center for Medical Mycology, Cleveland, Ohio, for testing the susceptibility of dermatophytes. Data from that study supported the introduction of this method for testing dermatophytes in the future version of the CLSI M38-A standard. In order for the method to be accepted by CLSI, appropriate quality control isolates needed to be identified. To that end, an interlaboratory study, involving the original six laboratories plus two additional sites, was conducted to evaluate potential candidates for quality control isolates. These candidate strains included five Trichophyton rubrum strains known to have elevated MICs to terbinafine and five Trichophyton mentagrophytes strains. Antifungal agents tested included ciclopirox, fluconazole, griseofulvin, itraconazole, posaconazole, terbinafine, and voriconazole. Based on the data generated, two quality control isolates, one T. rubrum isolate and one T. mentagrophytes isolate, were identified and submitted to the American Type Culture Collection (ATCC) for inclusion as reference strains. Ranges encompassing 95.2 to 97.9% of all data points for all seven drugs were established. PMID:17050812

42 CFR 493.1425 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's quality control policies, document all quality control activities, instrument and procedural... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity Testing § 493.1425 Standard; Testing personnel...

Determination of Amino Acids in Cell Culture and Fermentation Broth Media Using Anion-Exchange Chromatography with Integrated Pulsed Amperometric Detection

PubMed Central

Hanko, Valoran P.; Heckenberg, Andrea; Rohrer, Jeffrey S.

2004-01-01

Anion-exchange chromatography with integrated pulsed amperometric detection (AE-IPAD) separates and directly detects amino acids, carbohydrates, alditols, and glycols in the same injection without pre- or post-column derivatization. These separations use a combination of NaOH and NaOH/sodium acetate eluents. We previously published the successful use of this technique, also known as AAA-Direct, to determine free amino acids in cell culture and fermentation broth media. We showed that retention of carbohydrates varies with eluent NaOH concentration differently than amino acids, and thus separations can be optimized by varying the initial NaOH concentration and its duration. Unfortunately, some amino acids eluting in the acetate gradient portion of the method were not completely resolved from system-related peaks and from unknown peaks in complex cell culture and fermentation media. In this article, we present changes in method that improve amino acid resolution and system ruggedness. The success of these changes and their compatibility with the separations previously designed for fermentation and cell culture are demonstrated with yeast extract-peptone-dextrose broth, M199, Dulbecco’s modified Eagle’s (with F-12), L-15 (Leibovitz), and McCoy’s 5A cell culture media. PMID:15585828

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

PubMed

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency

Performance of serum-free broth media for growth of Renibacterium salmoninarum

USGS Publications Warehouse

Starliper, C.E.; Schill, W.B.; Mathias, J.

1998-01-01

Growth of Renibacterium salmoninarum was compared in 14 different broth media; 13 serum-free, and 1 that contained newborn calf serum, KDM2+M. Supplementation with 1% v/v R. salmoninarum MCO4M metabolite was evaluated for 6 of the media that do not utilize it as part of their ingredients. Viable cells were enumerated on Days 10, 20, and 30 post inoculation to evaluate performance. The experiment was repeated 3 times using high, low, and medium (trials 1 to 3, respectively) cell concentrations as inoculum. In general there was no optimal medium and all performed well. The choice of which to employ depends on the ease of preparation and presence of certain ingredients that might affect subsequent assays. In trials 2 and 3, the pH was estimated using test papers at the same time as cells were counted. Maximum pH increase occurred with KDM2+M and those media containing charcoal. For most media, a simple pH determination could be used as a means to check that growth has occurred in a culture, particularly if charcoal was added directly to the media and a visual inspection could not be made to detect growth.

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods.

PubMed

Weykamp, C W; Penders, T J; Miedema, K; Muskiet, F A; van der Slik, W

1995-01-01

We investigated the effect of calibration with lyophilized calibrators on whole-blood glycohemoglobin (glyHb) results. One hundred three laboratories, using 20 different methods, determined glyHb in two lyophilized calibrators and two whole-blood samples. For whole-blood samples with low (5%) and high (9%) glyHb percentages, respectively, calibration decreased overall interlaboratory variation (CV) from 16% to 9% and from 11% to 6% and decreased intermethod variation from 14% to 6% and from 12% to 5%. Forty-seven laboratories, using 14 different methods, determined mean glyHb percentages in self-selected groups of 10 nondiabetic volunteers each. With calibration their overall mean (2SD) was 5.0% (0.5%), very close to the 5.0% (0.3%) derived from the reference method used in the Diabetes Control and Complications Trial. In both experiments the Abbott IMx and Vision showed deviating results. We conclude that, irrespective of the analytical method used, calibration enables standardization of glyHb results, reference values, and interpretation criteria.

[Standardization in laboratory hematology by participating in external quality assurance programs].

PubMed

Nazor, Aida; Siftar, Zoran; Flegar-Mestrić, Zlata

2011-09-01

Since 1985, Department of Clinical Chemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, has been participating in the International External Quality Assessment Scheme for Hematology (IEQAS-H) organized by the World Health Organization (WHO). Owing to very good results, in 1987 the Department received a certificate of participation in this control scheme. Department has been cooperating in the external quality assessment program in laboratory hematology which has been continuously performed in Croatia since 1986 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists and School of Pharmacy and Biochemistry, University of Zagreb. Nowadays, 186 medical biochemical laboratories are included in the National External Quality Assessment program, which is performed three times per year. Our Department has participated in the international projects of the European Committee for External Quality Assurance Programs in Laboratory Medicine (EQALM).

40 CFR 160.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Laboratory operation areas. 160.49 Section 160.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.49 Laboratory operation areas. Separate laboratory...

40 CFR 160.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Laboratory operation areas. 160.49 Section 160.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.49 Laboratory operation areas. Separate laboratory...

Development of the Global Measles Laboratory Network.

PubMed

Featherstone, David; Brown, David; Sanders, Ray

2003-05-15

The routine reporting of suspected measles cases and laboratory testing of samples from these cases is the backbone of measles surveillance. The Global Measles Laboratory Network (GMLN) has developed standards for laboratory confirmation of measles and provides training resources for staff of network laboratories, reference materials and expertise for the development and quality control of testing procedures, and accurate information for the Measles Mortality Reduction and Regional Elimination Initiative. The GMLN was developed along the lines of the successful Global Polio Laboratory Network, and much of the polio laboratory infrastructure was utilized for measles. The GMLN has developed as countries focus on measles control activities following successful eradication of polio. Currently more than 100 laboratories are part of the global network and follow standardized testing and reporting procedures. A comprehensive laboratory accreditation process will be introduced in 2002 with six quality assurance and performance indicators.

Components of laboratory accreditation.

PubMed

Royal, P D

1995-12-01

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

Measuring laboratory-based influenza surveillance capacity: development of the 'International Influenza Laboratory Capacity Review' Tool.

PubMed

Muir-Paulik, S A; Johnson, L E A; Kennedy, P; Aden, T; Villanueva, J; Reisdorf, E; Humes, R; Moen, A C

2016-01-01

The 2005 International Health Regulations (IHR 2005) emphasized the importance of laboratory capacity to detect emerging diseases including novel influenza viruses. To support IHR 2005 requirements and the need to enhance influenza laboratory surveillance capacity, the Association of Public Health Laboratories (APHL) and the Centers for Disease Control and Prevention (CDC) Influenza Division developed the International Influenza Laboratory Capacity Review (Tool). Data from 37 assessments were reviewed and analyzed to verify that the quantitative analysis results accurately depicted a laboratory's capacity and capabilities. Subject matter experts in influenza and laboratory practice used an iterative approach to develop the Tool incorporating feedback and lessons learnt through piloting and implementation. To systematically analyze assessment data, a quantitative framework for analysis was added to the Tool. The review indicated that changes in scores consistently reflected enhanced or decreased capacity. The review process also validated the utility of adding a quantitative analysis component to the assessments and the benefit of establishing a baseline from which to compare future assessments in a standardized way. Use of the Tool has provided APHL, CDC and each assessed laboratory with a standardized analysis of the laboratory's capacity. The information generated is used to improve laboratory systems for laboratory testing and enhance influenza surveillance globally. We describe the development of the Tool and lessons learnt. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

A professional development model for medical laboratory scientists working in the immunohematology laboratory.

PubMed

Garza, Melinda N; Pulido, Lila A; Amerson, Megan; Ali, Faheem A; Greenhill, Brandy A; Griffin, Gary; Alvarez, Enrique; Whatley, Marsha; Hu, Peter C

2012-01-01

Transfusion medicine, a section of the Department of Laboratory Medicine at The University of Texas MD Anderson Cancer Center is committed to the education and advancement of its health care professionals. It is our belief that giving medical laboratory professionals a path for advancement leads to excellence and increases overall professionalism in the Immunohematology Laboratory. As a result of this strong commitment to excellence and professionalism, the Immunohematology laboratory has instituted a Professional Development Model (PDM) that aims to create Medical Laboratory Scientists (MLS) that are not only more knowledgeable, but are continually striving for excellence. In addition, these MLS are poised for advancement in their careers. The professional development model consists of four levels: Discovery, Application, Maturation, and Expert. The model was formulated to serve as a detailed path to the mastery of all process and methods in the Immunohematology Laboratory. Each level in the professional development model consists of tasks that optimize the laboratory workflow and allow for concurrent training. Completion of a level in the PDM is rewarded with financial incentive and further advancement in the field. The PDM for Medical Laboratory Scientists in the Immunohematology Laboratory fosters personal development, rewards growth and competency, and sets high standards for all services and skills provided. This model is a vital component of the Immunohematology Laboratory and aims to ensure the highest quality of care and standards in their testing. It is because of the success of this model and the robustness of its content that we hope other medical laboratories aim to reach the same level of excellence and professionalism, and adapt this model into their own environment.

International Organization for Standardization (ISO) 15189

PubMed Central

Schneider, Frank; Friedberg, Richard C.

2017-01-01

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. PMID:28643484

Detection of amphotericin B resistance in Candida haemulonii and closely related species by use of the Etest, Vitek-2 yeast susceptibility system, and CLSI and EUCAST broth microdilution methods.

PubMed

Shin, Jong Hee; Kim, Mi-Na; Jang, Sook Jin; Ju, Min Young; Kim, Soo Hyun; Shin, Myung Geun; Suh, Soon Pal; Ryang, Dong Wook

2012-06-01

The emerging fungal pathogens Candida haemulonii and Candida pseudohaemulonii often show high-level resistance to amphotericin B (AMB). We compared the utilities of five antifungal susceptibility testing methods, i.e., the Etest using Mueller-Hinton agar supplemented with glucose and methylene blue (Etest-MH), the Etest using RPMI agar supplemented with glucose (Etest-RPG), the Vitek-2 yeast susceptibility system, and the Clinical and Laboratory Standards Institute (CLSI) and European Committee on Antimicrobial Susceptibility Testing (EUCAST) broth microdilution methods, for the detection of AMB-resistant isolates of C. haemulonii and closely related species. Thirty-eight clinical isolates (8 C. haemulonii, 10 C. pseudohaemulonii, and 20 Candida auris isolates) were analyzed. Of the 18 C. haemulonii and C. pseudohaemulonii isolates, 18, 15, 18, 10, and 9 exhibited AMB MICs of >1 μg/ml by the Etest-MH, Etest-RPG, Vitek-2, CLSI, and EUCAST methods, respectively. All 20 C. auris isolates showed AMB MICs of ≤1 μg/ml by all five methods. Of the methods, the Etest-MH generated the broadest distribution of AMB MICs for all 38 isolates and showed the best discrimination between the C. haemulonii and C. pseudohaemulonii isolates (4 to 32 μg/ml) and those of C. auris (0.125 to 0.5 μg/ml). Taking the Etest-MH as the reference method, the essential agreements (within two dilutions) for the Etest-RPG, Vitek-2, CLSI, and EUCAST methods were 84, 92, 55, and 55%, respectively; the categorical agreements were 92, 92, 79, and 76%, respectively. This study provides the first data on the efficacy of the Etest-MH and its excellent agreement with Vitek-2 for discriminating AMB-resistant from AMB-susceptible isolates of these Candida species.

42 CFR 493.1230 - Condition: General laboratory systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory that...

Protocol standards and implementation within the digital engineering laboratory computer network (DELNET) using the universal network interface device (UNID). Part 2

NASA Astrophysics Data System (ADS)

Phister, P. W., Jr.

1983-12-01

Development of the Air Force Institute of Technology's Digital Engineering Laboratory Network (DELNET) was continued with the development of an initial draft of a protocol standard for all seven layers as specified by the International Standards Organization's (ISO) Reference Model for Open Systems Interconnections. This effort centered on the restructuring of the Network Layer to perform Datagram routing and to conform to the developed protocol standards and actual software module development of the upper four protocol layers residing within the DELNET Monitor (Zilog MCZ 1/25 Computer System). Within the guidelines of the ISO Reference Model the Transport Layer was developed utilizing the Internet Header Format (IHF) combined with the Transport Control Protocol (TCP) to create a 128-byte Datagram. Also a limited Application Layer was created to pass the Gettysburg Address through the DELNET. This study formulated a first draft for the DELNET Protocol Standard and designed, implemented, and tested the Network, Transport, and Application Layers to conform to these protocol standards.

Accuracy investigation of phthalate metabolite standards.

PubMed

Langlois, Éric; Leblanc, Alain; Simard, Yves; Thellen, Claude

2012-05-01

Phthalates are ubiquitous compounds whose metabolites are usually determined in urine for biomonitoring studies. Following suspect and unexplained results from our laboratory in an external quality-assessment scheme, we investigated the accuracy of all phthalate metabolite standards in our possession by comparing them with those of several suppliers. Our findings suggest that commercial phthalate metabolite certified solutions are not always accurate and that lot-to-lot discrepancies significantly affect the accuracy of the results obtained with several of these standards. These observations indicate that the reliability of the results obtained from different lots of standards is not equal, which reduces the possibility of intra-laboratory and inter-laboratory comparisons of results. However, agreements of accuracy have been observed for a majority of neat standards obtained from different suppliers, which indicates that a solution to this issue is available. Data accuracy of phthalate metabolites should be of concern for laboratories performing phthalate metabolite analysis because of the standards used. The results of our investigation are presented from the perspective that laboratories performing phthalate metabolite analysis can obtain accurate and comparable results in the future. Our findings will contribute to improving the quality of future phthalate metabolite analyses and will affect the interpretation of past results.

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

PubMed Central

Jang, Mi-Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong-Ho; Min, Won-Ki; Lee, Ji Sung

2017-01-01

Background Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. Methods We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Results Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. Conclusions These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. PMID:28224767

External quality assessment of medical laboratories in Croatia: preliminary evaluation of post-analytical laboratory testing.

PubMed

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana

2017-02-15

Proper standardization of laboratory testing requires assessment of performance after the tests are performed, known as the post-analytical phase. A nationwide external quality assessment (EQA) scheme implemented in Croatia in 2014 includes a questionnaire on post-analytical practices, and the present study examined laboratory responses in order to identify current post-analytical phase practices and identify areas for improvement. In four EQA exercises between September 2014 and December 2015, 145-174 medical laboratories across Croatia were surveyed using the Module 11 questionnaire on the post-analytical phase of testing. Based on their responses, the laboratories were evaluated on four quality indicators: turnaround time (TAT), critical values, interpretative comments and procedures in the event of abnormal results. Results were presented as absolute numbers and percentages. Just over half of laboratories (56.3%) monitored TAT. Laboratories varied substantially in how they dealt with critical values. Most laboratories (65-97%) issued interpretative comments with test results. One third of medical laboratories (30.6-33.3%) issued abnormal test results without confirming them in additional testing. Our results suggest that the nationwide post-analytical EQA scheme launched in 2014 in Croatia has yet to be implemented to the full. To close the gaps between existing recommendations and laboratory practice, laboratory professionals should focus on ensuring that TAT is monitored and lists of critical values are established within laboratories. Professional bodies/institutions should focus on clarify and harmonized rules to standardized practices and applied for adding interpretative comments to laboratory test results and for dealing with abnormal test results.

AMT's Position on Physician's Office Laboratories.

ERIC Educational Resources Information Center

AMT Events, 1986

1986-01-01

The following standards are affirmed by the American Medical Technologists organization: (1) regardless of the size of the laboratory setting, the patient deserves the highest quality of laboratory service available; (2) certified personnel should be employed by physicians in office laboratories; (3) quality control should be mandatory and…

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.

PubMed

Jang, Mi Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong Ho; Min, Won Ki; Lee, Ji Sung; Lee, Yong Wha; Lee, You Kyoung

2017-05-01

Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. © The Korean Society for Laboratory Medicine

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Laboratory operation areas. 792.49... CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas. Separate laboratory space and other space shall be provided, as needed, for the performance of the routine...

42 CFR 493.1234 - Standard: Communications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Communications. 493.1234 Section 493.1234 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Laboratory Systems § 493.1234 Standard: Communications. The laboratory must have a system in place to...

Laboratory issues: use of nutritional biomarkers.

PubMed

Blanck, Heidi Michels; Bowman, Barbara A; Cooper, Gerald R; Myers, Gary L; Miller, Dayton T

2003-03-01

Biomarkers of nutritional status provide alternative measures of dietary intake. Like the error and variation associated with dietary intake measures, the magnitude and impact of both biological (preanalytical) and laboratory (analytical) variability need to be considered when one is using biomarkers. When choosing a biomarker, it is important to understand how it relates to nutritional intake and the specific time frame of exposure it reflects as well as how it is affected by sampling and laboratory procedures. Biological sources of variation that arise from genetic and disease states of an individual affect biomarkers, but they are also affected by nonbiological sources of variation arising from specimen collection and storage, seasonality, time of day, contamination, stability and laboratory quality assurance. When choosing a laboratory for biomarker assessment, researchers should try to make sure random and systematic error is minimized by inclusion of certain techniques such as blinding of laboratory staff to disease status and including external pooled standards to which laboratory staff are blinded. In addition analytic quality control should be ensured by use of internal standards or certified materials over the entire range of possible values to control method accuracy. One must consider the effect of random laboratory error on measurement precision and also understand the method's limit of detection and the laboratory cutpoints. Choosing appropriate cutpoints and reducing error is extremely important in nutritional epidemiology where weak associations are frequent. As part of this review, serum lipids are included as an example of a biomarker whereby collaborative efforts have been put forth to both understand biological sources of variation and standardize laboratory results.

9 CFR 147.15 - Laboratory procedure recommended for the bacteriological examination of mycoplasma reactors. 11

Code of Federal Regulations, 2011 CFR

2011-01-01

.... W., Jr., “Mycoplasmosis.” In: Isolation and Identification of Avian Pathogens. (Stephen B. Hitchner... Scientific Company. (4) Mycoplasma Broth Base, dextrose, phenol red, and cysteine hydrochloride are added to... Mycoplasma Broth Base may be obtained from: (a) Product #M 33600, Gibco Diagnostics, 2801 Industrial Drive...

Appliance Standard Testing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hogan, Kathleen; Tiemann, Gregg

2016-08-03

The U.S. Department of Energy’s Appliance Standards and Equipment Program tests, sets and helps enforce efficiency standards on more than 60 U.S. products. A majority of that testing is performed at the Intertek laboratory in Cortland, NY.

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

Undergraduate Organic Chemistry Laboratory Safety

NASA Astrophysics Data System (ADS)

Luckenbaugh, Raymond W.

1996-11-01

Each organic chemistry student should become familiar with the educational and governmental laboratory safety requirements. One method for teaching laboratory safety is to assign each student to locate safety resources for a specific class laboratory experiment. The student should obtain toxicity and hazardous information for all chemicals used or produced during the assigned experiment. For example, what is the LD50 or LC50 for each chemical? Are there any specific hazards for these chemicals, carcinogen, mutagen, teratogen, neurotixin, chronic toxin, corrosive, flammable, or explosive agent? The school's "Chemical Hygiene Plan", "Prudent Practices for Handling Hazardous Chemicals in the Laboratory" (National Academy Press), and "Laboratory Standards, Part 1910 - Occupational Safety and Health Standards" (Fed. Register 1/31/90, 55, 3227-3335) should be reviewed for laboratory safety requirements for the assigned experiment. For example, what are the procedures for safe handling of vacuum systems, if a vacuum distillation is used in the assigned experiment? The literature survey must be submitted to the laboratory instructor one week prior to the laboratory session for review and approval. The student should then give a short presentation to the class on the chemicals' toxicity and hazards and describe the safety precautions that must be followed. This procedure gives the student first-hand knowledge on how to find and evaluate information to meet laboartory safety requirements.

CTBTO Contractor Laboratory Test Sample Production Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bob Hague; Tracy Houghton; Nick Mann

2013-08-01

In October 2012 scientists from both Idaho National Laboratory (INL) and the CTBTO contact laboratory at Seibersdorf, Austria designed a system and capability test to determine if the INL could produce and deliver a short lived radio xenon standard in time for the standard to be measured at the CTBTO contact laboratory at Seibersdorf, Austria. The test included sample standard transportation duration and potential country entrance delays at customs. On October 23, 2012 scientists at the Idaho National Laboratory (INL) prepared and shipped a Seibersdorf contract laboratory supplied cylinder. The canister contained 1.0 scc of gas that consisted of 70%more » xenon and 30% nitrogen by volume. The t0 was October 24, 2012, 1200 ZULU. The xenon content was 0.70 +/ 0.01 scc at 0 degrees C. The 133mXe content was 4200 +/ 155 dpm per scc of stable xenon on t0 (1 sigma uncertainty). The 133Xe content was 19000 +/ 800 dpm per scc of stable xenon on t0 (1 sigma uncertainty).« less

Potency of marbofloxacin for pig pneumonia pathogens Actinobacillus pleuropneumoniae and Pasteurella multocida: Comparison of growth media.

PubMed

Dorey, L; Hobson, S; Lees, P

2017-04-01

Pharmacodynamic properties of marbofloxacin were established for six isolates each of the pig respiratory tract pathogens, Actinobacillus pleuropneumoniae and Pasteurella multocida. Three in vitro indices of potency were determined; Minimum Inhibitory Concentration (MIC), Minimum Bactericidal Concentration (MBC) and Mutant Prevention Concentration (MPC). For MIC determination Clinical Laboratory Standards Institute guidelines were modified in three respects: (1) comparison was made between two growth media, an artificial broth and pig serum; (2) a high inoculum count was used to simulate heavy clinical bacteriological loads; and (3) five overlapping sets of two-fold dilutions were used to improve accuracy of determinations. Similar methods were used for MBC and MPC estimations. MIC and MPC serum:broth ratios for A. pleuropneumoniae were 0.79:1 and 0.99:1, respectively, and corresponding values for P. multocida were 1.12:1 and 1.32:1. Serum protein binding of marbofloxacin was 49%, so that fraction unbound (fu) serum MIC values were significantly lower than those predicted by correction for protein binding; fu serum:broth MIC ratios were 0.40:1 (A. pleuropneumoniae) and 0.50:1 (P. multocida). For broth, MPC:MIC ratios were 13.7:1 (A. pleuropneumoniae) and 14.2:1 (P. multocida). Corresponding ratios for serum were similar, 17.2:1 and 18.8:1, respectively. It is suggested that, for dose prediction purposes, serum data might be preferable to potency indices measured in broths. Copyright © 2016 Elsevier Ltd. All rights reserved.

National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas.

PubMed

Yeh, Kenneth B; Adams, Martin; Stamper, Paul D; Dasgupta, Debanjana; Hewson, Roger; Buck, Charles D; Richards, Allen L; Hay, John

2016-01-01

Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community.

National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas

PubMed Central

Adams, Martin; Stamper, Paul D.; Dasgupta, Debanjana; Hewson, Roger; Buck, Charles D.; Richards, Allen L.; Hay, John

2016-01-01

Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community. PMID:27559843

Laboratory Safety is Everyone's Responsibility.

ERIC Educational Resources Information Center

Brubaker, Inara M.; And Others

1981-01-01

Outlines a survey of laboratory practices and policies for employee protection from exposure to chemicals. Findings support the argument that academic, industrial, and other research laboratories are different from the manufacturing environment and should have a different toxic chemical policy and standards. (Author/SK)

Laboratory automation: total and subtotal.

PubMed

Hawker, Charles D

2007-12-01

Worldwide, perhaps 2000 or more clinical laboratories have implemented some form of laboratory automation, either a modular automation system, such as for front-end processing, or a total laboratory automation system. This article provides descriptions and examples of these various types of automation. It also presents an outline of how a clinical laboratory that is contemplating automation should approach its decision and the steps it should follow to ensure a successful implementation. Finally, the role of standards in automation is reviewed.

Effects of the Essential Oil from Origanum vulgare L. on Survival of Pathogenic Bacteria and Starter Lactic Acid Bacteria in Semihard Cheese Broth and Slurry.

PubMed

de Souza, Geany Targino; de Carvalho, Rayssa Julliane; de Sousa, Jossana Pereira; Tavares, Josean Fechine; Schaffner, Donald; de Souza, Evandro Leite; Magnani, Marciane

2016-02-01

This study assessed the inhibitory effects of the essential oil from Origanum vulgare L. (OVEO) on Staphylococcus aureus, Listeria monocytogenes, and a mesophilic starter coculture composed of lactic acid bacteria (Lactococcus lactis subsp. lactis and L. lactis subsp. cremoris) in Brazilian coalho cheese systems. The MIC of OVEO was 2.5 μl/ml against both S. aureus and L. monocytogenes and 0.6 μl/ml against the tested starter coculture. In cheese broth containing OVEO at 0.6 μl/ml, no decrease in viable cell counts (VCC) of both pathogenic bacteria was observed, whereas the initial VCC of the starter coculture decreased approximately 1.0 log CFU/ml after 24 h of exposure at 10°C. OVEO at 1.25 and 2.5 μl/ml caused reductions of up to 2.0 and 2.5 log CFU/ml in S. aureus and L. monocytogenes, respectively, after 24 h of exposure in cheese broth. At these same concentrations, OVEO caused a greater decrease of initial VCC of the starter coculture following 4 h of exposure. Higher concentrations of OVEO were required to decrease the VCC of all target bacteria in semisolid coalho cheese slurry compared with cheese broth. The VCC of Lactococcus spp. in coalho cheese slurry containing OVEO were always lower than those of pathogenic bacteria under the same conditions. These results suggest that the concentrations of OVEO used to control pathogenic bacteria in semihard cheese should be carefully evaluated because of its inhibitory effects on the growth of starter lactic acid cultures used during the production of the product.

Appliance Standard Testing

ScienceCinema

Hogan, Kathleen; Tiemann, Gregg

2018-01-16

The U.S. Department of Energy’s Appliance Standards and Equipment Program tests, sets and helps enforce efficiency standards on more than 60 U.S. products. A majority of that testing is performed at the Intertek laboratory in Cortland, NY.

Direct detection of methicillin resistance in Staphylococcus aureus in blood culture broth by use of a penicillin binding protein 2a latex agglutination test.

PubMed

Qian, Qinfang; Venkataraman, Lata; Kirby, James E; Gold, Howard S; Yamazumi, Toshiaki

2010-04-01

We studied the utility of performing a penicillin binding protein 2a latex agglutination (PBP-LA) assay directly on Bactec blood culture broth samples containing Staphylococcus aureus to rapidly detect methicillin resistance. The sensitivity, specificity, positive predictive value, and negative predictive value of this method were 94.1%, 97.5%, 98%, and 92.9%, respectively.

[The fundamental role of stage control technology on the detectability for Salmonella networking laboratory].

PubMed

Zhou, Yong-ming; Chen, Xiu-hua; Xu, Wen; Jin, Hui-ming; Li, Chao-qun; Liang, Wei-li; Wang, Duo-chun; Yan, Mei-ying; Lou, Jing; Kan, Biao; Ran, Lu; Cui, Zhi-gang; Wang, Shu-kun; Xu, Xue-bin

2013-11-01

To evaluated the fundamental role of stage control technology (SCT) on the detectability for Salmonella networking laboratories. Appropriate Salmonella detection methods after key point control being evaluated, were establishment and optimized. Our training and evaluation networking laboratories participated in the World Health Organization-Global Salmonella Surveillance Project (WHO-GSS) and China-U.S. Collaborative Program on Emerging and Re-emerging infectious diseases Project (GFN) in Shanghai. Staff members from the Yunnan Yuxi city Center for Disease Control and Prevention were trained on Salmonella isolation from diarrhea specimens. Data on annual Salmonella positive rates was collected from the provincial-level monitoring sites to be part of the GSS and GFN projects from 2006 to 2012. The methodology was designed based on the conventional detection procedure of Salmonella which involved the processes as enrichment, isolation, species identification and sero-typing. These methods were simultaneously used to satisfy the sensitivity requirements on non-typhoid Salmonella detection for networking laboratories. Public Health Laboratories in Shanghai had developed from 5 in 2006 to 9 in 2011, and Clinical laboratories from 8 to 22. Number of clinical isolates, including typhoid and non-typhoid Salmonella increased from 196 in 2006 to 1442 in 2011. The positive rate of Salmonella isolated from the clinical diarrhea cases was 2.4% in Yuxi county, in 2012. At present, three other provincial monitoring sites were using the SBG technique as selectivity enrichment broth for Salmonella isolation, with Shanghai having the most stable positive baseline. The method of SCT was proved the premise of the network laboratory construction. Based on this, the improvement of precise phenotypic identification and molecular typing capabilities could reach the level equivalent to the national networking laboratory.

Inter-Laboratory Comparison for Calibration of Relative Humidity Devices Among Accredited Laboratories in Malaysia

NASA Astrophysics Data System (ADS)

Hussain, F.; Khairuddin, S.; Othman, H.

2017-01-01

An inter-laboratory comparison in relative humidity measurements among accredited laboratories has been coordinated by the National Metrology Institute of Malaysia. It was carried out to determine the performance of the participating laboratories. The objective of the comparison was to acknowledge the participating laboratories competencies and to verify the level of accuracies declared in their scope of accreditation, in accordance with the MS ISO/IEC 17025 accreditation. The measurement parameter involved was relative humidity for the range of 30-90 %rh at a nominal temperature of 50°C. Eight accredited laboratories participated in the inter-laboratory comparison. Two units of artifacts have been circulated among the participants as the transfer standards.

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

42 CFR 493.1232 - Standard: Specimen identification and integrity.

Code of Federal Regulations, 2011 CFR

2011-10-01

... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1232 Standard: Specimen identification and integrity. The laboratory must establish and follow written policies and procedures that ensure positive identification and...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Laboratory operation areas. 792.49 Section 792.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... specific component, drug product container, closure, in-process material, or drug product, and lot tested... product container, closure, in-process material, or drug product tested. (7) The initials or signature of... of any testing and standardization of laboratory reference standards, reagents, and standard...

Dental Laboratory Technology Program Guide.

ERIC Educational Resources Information Center

Georgia Univ., Athens. Dept. of Vocational Education.

This program guide contains the standard dental laboratory technology curriculum for both diploma programs and associate degree programs in technical institutes in Georgia. The curriculum encompasses the minimum competencies required for entry-level workers in the dental laboratory technology field. The general information section contains the…

Wild-Type MIC Distributions and Epidemiological Cutoff Values for Caspofungin and Aspergillus spp. for the CLSI Broth Microdilution Method (M38-A2 Document)▿

PubMed Central

Espinel-Ingroff, A.; Fothergill, A.; Fuller, J.; Johnson, E.; Pelaez, T.; Turnidge, J.

2011-01-01

Clinical breakpoints have not been established for mold testing. Epidemiologic cutoff values (ECVs) are available for six Aspergillus spp. and the triazoles, but not for caspofungin. Wild-type (WT) minimal effective concentration (MEC) distributions (organisms in a species-drug combination with no acquired resistance mechanisms) were defined in order to establish ECVs for six Aspergillus spp. and caspofungin. The number of available isolates was as follows: 1,691 A. fumigatus, 432 A. flavus, 192 A. nidulans, 440 A. niger, 385 A. terreus, and 75 A. versicolor isolates. CLSI broth microdilution MEC data gathered in five independent laboratories in Canada, Europe, and the United States were aggregated for the analyses. ECVs expressed in μg/ml that captured 95% and 99% of the modeled wild-type population were for A. fumigatus 0.5 and 1, A. flavus 0.25 and 0.5, A. nidulans 0.5 and 0.5, A. niger 0.25 and 0.25, A. terreus 0.25 and 0.5, and A. versicolor 0.25 and 0.5. Although caspofungin ECVs are not designed to predict the outcome of therapy, they may aid in the detection of strains with reduced antifungal susceptibility to this agent and acquired resistance mechanisms. PMID:21422219

Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457).

PubMed

Lee, Ji In; Kim, Ji Young; Choi, Joon Young; Kim, Hee Kyung; Jang, Hye Won; Hur, Kyu Yeon; Kim, Jae Hyeon; Kim, Kwang-Won; Chung, Jae Hoon; Kim, Sun Wook

2010-09-01

Serum thyroglobulin (Tg) is essential in the follow-up of patients with differentiated thyroid carcinoma (DTC). However, interchangeability and standardization between Tg assays have not yet been achieved, even with the development of an international Tg standard (Certified Reference Material 457 [CRM-457]). Serum Tg from 30 DTC patients and serially diluted CRM-457 were measured using 3 different immunoradiometric assays (IRMA-1, IRMA-2, IRMA-3). The intraclass correlation coefficient (ICC) method was used to describe the concordance of each IRMA to CRM-457. The serum Tg measured by 3 different IRMAs correlated well (r > .85, p < .0001), but clinically relevant discrepancies were found in 13.3% of patients. IRMA-3, which claims to be standardized to CRM-457, showed the best ICC (p(1) = .98) for the CRM-457. Hospitals caring for patients with DTC should either set their own cutoffs for IRMAs for Tg based on their patient pools, or adopt IRMAs standardized to CRM-457 and calibrate their laboratory using CRM-457.

Situation analysis of occupational and environmental health laboratory accreditation in Thailand.

PubMed

Sithisarankul, Pornchai; Santiyanont, Rachana; Wongpinairat, Chongdee; Silva, Panadda; Rojanajirapa, Pinnapa; Wangwongwatana, Supat; Srinetr, Vithet; Sriratanaban, Jiruth; Chuntutanon, Swanya

2002-06-01

The objective of this study was to analyze the current situation of laboratory accreditation (LA) in Thailand, especially on occupational and environmental health. The study integrated both quantitative and qualitative approaches. The response rate of the quantitative questionnaires was 54.5% (226/415). The majority of the responders was environmental laboratories located outside hospital and did not have proficiency testing. The majority used ISO 9000, ISO/IEC 17025 or ISO/ EEC Guide 25, and hospital accreditation (HA) as their quality system. However, only 30 laboratories were currently accredited by one of these systems. Qualitative research revealed that international standard for laboratory accreditation for both testing laboratory and calibration laboratory was ISO/IEC Guide 25, which has been currently revised to be ISO/IEC 17025. The National Accreditation Council (NAC) has authorized 2 organizations as Accreditation Bodies (ABs) for LA: Thai Industrial Standards Institute, Ministry of Industry, and Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health. Regarding LA in HA, HA considered clinical laboratory as only 1 of 31 items for accreditation. Obtaining HA might satisfy the hospital director and his management team, and hence might actually be one of the obstacles for the hospital to further improve their laboratory quality system and apply for ISO/IEC 17025 which was more technically oriented. On the other hand, HA may be viewed as a good start or even a pre-requisite for laboratories in the hospitals to further improve their quality towards ISO/IEC 17025. Interviewing the director of NAC and some key men in some large laboratories revealed several major problems of Thailand's LA. Both Thai Industrial Standards Institute and Bureau of Laboratory Quality Standards did not yet obtain Mutual Recognition Agreement (MRA) with other international ABs. Several governmental bodies had their own standards and

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

Behavioral Health and Performance Laboratory Standard Measures (BHP-SM)

NASA Technical Reports Server (NTRS)

Williams, Thomas J.; Cromwell, Ronita

2017-01-01

The Spaceflight Standard Measures is a NASA Johnson Space Center Human Research Project (HRP) project that proposes to collect a set of core measurements, representative of many of the human spaceflight risks, from astronauts before, during and after long-duration International Space Station (ISS) missions. The term "standard measures" is defined as a set of core measurements, including physiological, biochemical, psychosocial, cognitive, and functional, that are reliable, valid, and accepted in terrestrial science, are associated with a specific and measurable outcome known to occur as a consequence of spaceflight, that will be collected in a standardized fashion from all (or most) crewmembers. While such measures might be used to define standards of health and performance or readiness for flight, the prime intent in their collection is to allow longitudinal analysis of multiple parameters in order to answer a variety of operational, occupational, and research-based questions. These questions are generally at a high level, and the approach for this project is to populate the standard measures database with the smallest set of data necessary to indicate further detailed research is required. Also included as standard measures are parameters that are not outcome-based in and of-themselves, but provide ancillary information that supports interpretation of the outcome measures, e.g., nutritional assessment, vehicle environmental parameters, crew debriefs, etc. The project's main aim is to ensure that an optimized minimal set of measures is consistently captured from all ISS crewmembers until the end of Station in order to characterize the human in space. -This allows the HRP to identify, establish, and evaluate a common set of measures for use in spaceflight and analog research to: develop baselines, systematically characterize risk likelihood and consequences, and assess effectiveness of countermeasures that work for behavioral health and performance risk factors

Growth of the Bacteriocin-Producing Lactobacillus sakei Strain CTC 494 in MRS Broth Is Strongly Reduced Due to Nutrient Exhaustion: a Nutrient Depletion Model for the Growth of Lactic Acid Bacteria

PubMed Central

Leroy, Frédéric; De Vuyst, Luc

2001-01-01

Although commercial MRS broth has been designed to allow excellent growth of lactobacilli, most of these bacteria are still subjected to a self-inhibiting process. The most likely explanation is the accumulation of lactic acid or other toxic end products and the depletion of nutrients. In this study, the self-inhibition of Lactobacillus sakei CTC 494 was analyzed in a kinetic way, and a nutrient depletion model was set up to describe the growth inhibition process. This simple model has considerable advantages compared to commonly used descriptive models such as the logistic growth equation. It offers a better fit and a more realistic description of the growth data by taking into account both growth inhibition due to lactic acid production and changes in growth rates due to nutrient depletion. Depending on the fermentation conditions, in MRS broth there appears to be a strong decrease of the specific growth rate over time. Some undefined compounds present in the complex nitrogen source of MRS broth appear to be of crucial importance because of their limited availability. Moreover, nutrient availability affects bacteriocin production through its effect on cell growth as well as on the bacteriocin production per cell. A plateau value for the bacteriocin production by L. sakei CTC 494 was observed. PMID:11571136

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I.

PubMed

Guzel, Omer; Guner, Ebru Ilhan

2009-03-01

Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has

The quality and scope of information provided by medical laboratories to patients before laboratory testing: Survey of the Working Group for Patient Preparation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Nikolac, Nora; Simundic, Ana-Maria; Kackov, Sanja; Serdar, Tihana; Dorotic, Adrijana; Fumic, Ksenija; Gudasic-Vrdoljak, Jelena; Klenkar, Kornelija; Sambunjak, Jadranka; Vidranski, Valentina

2015-10-23

The aim of this work was to evaluate to what extent the scope and content of information provided to patients is standardized across medical biochemistry laboratories in Croatia. Two on-line self-report surveys were sent out: Survey A regarding attitudes on importance of patient preparation and Survey B on the contents of patient preparation instructions. 13/118 laboratories (11%) do not provide written instructions to patients on how to prepare for laboratory testing, and 36 (40%) do not include information about water intake in their instructions. Only half of laboratories provide instructions for prostate-specific antigen (53.8%), female sex hormones (53.7%) and therapeutic drug monitoring (TDM) (52.5%). Inadequate information about fasting status (55.0%) and 24 hour urine collection (77.9%) were frequent errors with high severity and were associated with the greatest potential to cause patient harm. Laboratory professionals in Croatia have a positive attitude towards the importance of patient preparation for laboratory testing. However, the information for laboratory testing is not standardized and frequently lacks guidance for tests related to TDM, coagulation and endocrinology. This study highlights the need for standardized, updated and evidence-based recommendations for patient preparation in order to minimize the risk for patients. Copyright © 2015 Elsevier B.V. All rights reserved.

42 CFR 493.1283 - Standard: Test records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (a) The laboratory must maintain an information or record system that includes the following: (1) The positive identification of the specimen. (2) The date and...

Purification of nattokinase by reverse micelles extraction from fermentation broth: effect of temperature and phase volume ratio.

PubMed

Liu, Jun-Guo; Xing, Jian-Min; Chang, Tian-Shi; Liu, Hui-Zhou

2006-03-01

Nattokinase is a novel fibrinolytic enzyme that is considered to be a promising agent for thrombosis therapy. In this study, reverse micelles extraction was applied to purify and concentrate nattokinase from fermentation broth. The effects of temperature and phase volume ratio used for the forward and backward extraction on the extraction process were examined. The optimal temperature for forward and backward extraction were 25 degrees C and 35 degrees C respectively. Nattokinase became more thermosensitive during reverse micelles extraction. And it could be enriched in the stripping phase eight times during backward extraction. It was found that nattokinase could be purified by AOT reverse micelles with up to 80% activity recovery and with a purification factor of 3.9.

Growth and inactivation of Salmonella enterica and Listeria monocytogenes in broth and validation in ground pork meat during simulated home storage abusive temperature and home pan-frying

PubMed Central

Wang, Xiang; Lahou, Evy; De Boeck, Elien; Devlieghere, Frank; Geeraerd, Annemie; Uyttendaele, Mieke

2015-01-01

Ground pork meat with natural microbiota and inoculated with low initial densities (1–10 or 10–100 CFU/g) of Salmonella enterica or Listeria monocytogenes was stored under abusive temperature at 10°C and thermally treated by a simulated home pan-frying procedure. The growth and inactivation characteristics were also evaluated in broth. In ground pork meat, the population of S. enterica increased by less than one log after 12-days of storage at 10°C, whereas L. monocytogenes increased by 2.3 to 2.8 log units. No unusual intrinsic heat resistance of the pathogens was noted when tested in broth at 60°C although shoulders were observed on the inactivation curves of L. monocytogenes. After growth of S. enterica and L. monocytogenes at 10°C for 5 days to levels of 1.95 log CFU/g and 3.10 log CFU/g, respectively, in ground pork meat, their inactivation in the burger subjected to a simulated home pan-frying was studied. After thermal treatment S. enterica was undetectable but L. monocytogenes was recovered in three out of six of the 25 g burger samples. Overall, the present study shows that data on growth and inactivation of broths are indicative but may underestimate as well as overestimate behavior of pathogens and thus need confirmation in food matrix conditions to assess food safety in reasonably foreseen abusive conditions of storage and usual home pan-frying of meat burgers in Belgium. PMID:26579079

Enzymatic activity, osmotic stress and degradation of pesticide mixtures in soil extract liquid broth inoculated with Phanerochaete chrysosporium and Trametes versicolor.

PubMed

Fragoeiro, Silvia; Magan, Naresh

2005-03-01

In this study we examined the extracellular enzymatic activity of two white rot fungi (Phanerochaete chrysosporium and Trametes versicolor) in a soil extract broth in relation to differential degradation of a mixture of different concentrations (0-30 p.p.m.) of simazine, dieldrin and trifluralin under different osmotic stress (-0.7 and -2.8 MPa) and quantified enzyme production, relevant to P and N release (phosphomonoesterase, protease), carbon cycling (beta-glucosidase, cellulase) and laccase activity, involved in lignin degradation. Our results suggest that T. versicolor and P. chrysosporium have the ability to degrade different groups of pesticides, supported by the capacity for expression of a range of extracellular enzymes at both -0.7 and -2.8 MPa water potential. Phanerochaete chrysosporium was able to degrade this mixture of pesticides independently of laccase activity. In soil extract, T. versicolor was able to produce the same range of enzymes as P. chrysoporium plus laccase, even in the presence of 30 p.p.m. of the pesticide mixture. Complete degradation of dieldrin and trifluralin was observed, while about 80% of the simazine was degraded regardless of osmotic stress treatment in a nutritionally poor soil extract broth. The capacity of tolerance and degradation of high concentrations of mixtures of pesticides and production of a range of enzymes, even under osmotic stress, suggest potential bioremediation applications.

Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan

PubMed Central

Elduma, Adel Hussein

2012-01-01

Background This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. Methods A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. Results The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. Conclusion The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too. PMID:22514753

Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan.

PubMed

Elduma, Adel Hussein

2012-01-01

This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too.

National Vehicle and Fuel Emissions Laboratory (NVFEL)

EPA Pesticide Factsheets

NVFEL is the primary EPA research laboratory used for fuel and emissions testing. The laboratory supports emission standards for motor vehicles, engines, and fuels, as well as the development of automotive technology.

Safety in the Chemical Laboratory: The Selection of Eyewash Stations for Laboratory Use.

ERIC Educational Resources Information Center

Walters, Douglas B.; And Others

1988-01-01

Evaluates and compares common eyewash stations currently being used in laboratories. Discusses types available, installation, water supply needs, and maintenance. Lists current OSHA eyewash station standards. (ML)

10 CFR 431.18 - Testing laboratories.

Code of Federal Regulations, 2010 CFR

2010-01-01

... EQUIPMENT Electric Motors Test Procedures, Materials Incorporated and Methods of Determining Efficiency... Technology/National Voluntary Laboratory Accreditation Program (NIST/NVLAP); or (2) A laboratory... of the National Institute of Standards and Technology (NIST) which is part of the U.S. Department of...

Harmonization in laboratory medicine: Requests, samples, measurements and reports.

PubMed

Plebani, Mario

2016-01-01

In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide

The gallium melting-point standard: its application and evaluation for temperature measurements in the clinical laboratory.

PubMed

Bowers, G N; Inman, S R

1977-01-01

We are impressed with the ease and certainty of calibration electronic thermometers with thermistor probes to +/- 0.01 degree C at the gallium melting point, 29.771(4) degrees C. The IFCC reference method for measuring aspartate aminotransferase activity in serum was run at the reaction temperature of 29.771(4) degrees C. By constantly referencing to gallium as an integral part of the assay procedure, we determined the absolute reaction temperature to IPTS-68 (International Practical Temperature Scale of 1968) to +/- 0.02 degrees C. This unique temperature calibration standard near the center of the range of temperatures commonly used in the clinical laboratory is a valuable addition and can be expected to improve the accuracy of measurements, especially in clinical enzymology.

Safety in the Chemical Laboratory

ERIC Educational Resources Information Center

Steere, Norman V., Ed.

1975-01-01

The National Fire Protection Association has proposed national standards dealing with laboratory operations, ventilation, chemical handling and storage, compressed gases, fire prevention, and emergency procedures. The standards are likely to be used as guidelines by insurance companies, and governmental agencies that award grants and contracts for…

A Laboratory Safety Program at Delaware.

ERIC Educational Resources Information Center

Whitmyre, George; Sandler, Stanley I.

1986-01-01

Describes a laboratory safety program at the University of Delaware. Includes a history of the program's development, along with standard safety training and inspections now being implemented. Outlines a two-day laboratory safety course given to all graduate students and staff in chemical engineering. (TW)

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

Characteristics of The Narrow Spectrum Beams Used in the Secondary Standard Dosimetry Laboratory at the Lebanese Atomic Energy Commission.

PubMed

Melhem, N; El Balaa, H; Younes, G; Al Kattar, Z

2017-06-15

The Secondary Standard Dosimetry Laboratory at the Lebanese Atomic Energy Commission has different calibration methods for various types of dosimeters used in industrial, military and medical fields. The calibration is performed using different beams of X-rays (low and medium energy) and Gamma radiation delivered by a Cesium 137 source. The Secondary Standard Dosimetry laboratory in charge of calibration services uses different protocols for the determination of high and low air kerma rate and for narrow and wide series. In order to perform this calibration work, it is very important to identify all the beam characteristics for the different types of sources and qualities of radiation. The following work describes the methods used for the determination of different beam characteristics and calibration coefficients with their uncertainties in order to enhance the radiation protection of workers and patient applications in the fields of medical diagnosis and industrial X-ray. All the characteristics of the X-ray beams are determined for the narrow spectrum series in the 40 and 200 keV range where the inherent filtration, the current intensity, the high voltage, the beam profile and the total uncertainty are the specific characteristics of these X-ray beams. An X-ray software was developed in order to visualize the reference values according to the characteristics of each beam. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

78 FR 73208 - Underwriters Laboratories, Inc.: Application for Expansion

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-05

... Laboratories, Inc., requests the addition of multiple test standards to its scope of recognition. This... Laboratory (NRTL). UL requests the addition of multiple test standards to their NRTL scope of recognition... recognition has three elements: (1) The type of products the NRTL may test, with each type specified by its...

42 CFR 493.551 - General requirements for laboratories.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false General requirements for laboratories. 493.551... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program § 493.551...

42 CFR 493.551 - General requirements for laboratories.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false General requirements for laboratories. 493.551... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program § 493.551...

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

PubMed

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

[Study of quality of a branch laboratory--an opinion of a laboratory manager].

PubMed

Yazawa, Naoyuki

2006-11-01

At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

Laboratories new to the ICRM.

PubMed

Karam, Lisa; Anagnostakis, Marios J; Gudelis, Arunas; Marsoem, Pujadi; Mauring, Alexander; Wurdiyanto, Gatot; Yücel, Ülkü

2012-09-01

The Scientific Committee of the ICRM decided, for the 2011 Conference, to present laboratories that are at a key developmental stage in establishing, expanding or applying radionuclide metrology capabilities. The expansion of radionuclide metrology capabilities is crucial to meet evolving and emerging needs in health care, environmental monitoring, and nuclear energy. Five laboratories (from Greece, Lithuania, Indonesia, Norway and Turkey) agreed to participate. Each laboratory is briefly introduced, and examples of their capabilities and standardization activities are discussed. Published by Elsevier Ltd.

Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

PubMed

Simundic, A M; Cornes, M; Grankvist, K; Lippi, G; Nybo, M

2014-05-15

Standardized protocols for patient preparation for laboratory testing are currently lacking. Moreover, a great heterogeneity exists in the definitions of "fasting" currently being used among healthcare workers and in the literature. Marked metabolic and hormonal changes occur after food ingestion, mainly due to the absorption of fluids, lipids, proteins, carbohydrates and other food constituents. This postprandial response varies markedly in response to numerous factors, such as eating behavior, food composition, fasting duration, time of the day, chronic and acute smoking, coffee and alcohol consumption. It is therefore crucial to minimize the total variability by controlling as many of these modifying factors as possible. Control of the abovementioned effects on postprandial response can only be achieved by standardizing the way patients are prepared for laboratory testing, i.e. by defining the fasting duration, as well as what is and what is not allowed (e.g., coffee, tea, smoking, water) during the period of fasting prior to sample collection. The aim of this article is to describe the range of effects of different approaches to fasting on laboratory tests, and to provide a framework for the harmonization of definitions for fasting requirements for laboratory tests. Copyright © 2013 Elsevier B.V. All rights reserved.

Microbial cell disruption for improving lipid recovery using pressurized CO2 : Role of CO2 solubility in cell suspension, sugar broth, and spent media.

PubMed

Howlader, Md Shamim; French, William Todd; Shields-Menard, Sara A; Amirsadeghi, Marta; Green, Magan; Rai, Neeraj

2017-05-01

The study of in situ gas explosion to lyse the triglyceride-rich cells involves the solubilization of gas (e.g., carbon dioxide, CO 2 ) in lipid-rich cells under pressure followed by a rapid decompression, which allows the gas inside the cell to rapidly expand and rupture the cell from inside out. The aim of this study was to perform the cell disruption using pressurized CO 2 as well as to determine the solubility of CO 2 in Rhodotorula glutinis cell suspension, sugar broth media, and spent media. Cell disruption of R. glutinis was performed at two pressures of 2,000 and 3,500 kPa, respectively, at 295.2 K, and it was found from both scanning electron microscopy (SEM) and plate count that a substantial amount of R. glutinis was disrupted due to the pressurized CO 2 . We also found a considerable portion of lipid present in the aqueous phase after the disruption at P = 3,500 kPa compared to control (no pressure) and P = 2,000 kPa, which implied that more intracellular lipid was released due to the pressurized CO 2 . Solubility of CO 2 in R. glutinis cell suspension was found to be higher than the solubility of CO 2 in both sugar broth media and spent media. Experimental solubility was correlated using the extended Henry's law, which showed a good agreement with the experimental data. Enthalpy and entropy of dissolution of CO 2 were found to be -14.22 kJ mol -1 and 48.10 kJ mol -1  K -1 , 9.64 kJ mol -1 and 32.52 kJ mol -1  K -1 , and 7.50 kJ mol -1 and 25.22 kJ mol -1  K -1 in R. glutinis, spent media, and sugar broth media, respectively. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:737-748, 2017. © 2017 American Institute of Chemical Engineers.

42 CFR 493.1806 - Available sanctions: All laboratories.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Available sanctions: All laboratories. 493.1806... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1806 Available sanctions: All laboratories. (a) Applicability. CMS may impose one or more of the sanctions...

42 CFR 493.1806 - Available sanctions: All laboratories.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Available sanctions: All laboratories. 493.1806... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1806 Available sanctions: All laboratories. (a) Applicability. CMS may impose one or more of the sanctions...

Epidemiology of Salmonella sp. in California cull dairy cattle: prevalence of fecal shedding and diagnostic accuracy of pooled enriched broth culture of fecal samples

PubMed Central

Abu Aboud, Omran A.; Adaska, John M.; Williams, Deniece R.; Rossitto, Paul V.; Champagne, John D.; Lehenbauer, Terry W.; Atwill, Robert; Li, Xunde

2016-01-01

Background The primary objective of this cross-sectional study was to estimate the crude, seasonal and cull-reason stratified prevalence of Salmonella fecal shedding in cull dairy cattle on seven California dairies. A secondary objective was to estimate and compare the relative sensitivity (Se) and specificity (Sp) for pools of 5 and 10 enriched broth cultures of fecal samples for Salmonella sp. detection. Methods Seven dairy farms located in the San Joaquin Valley of California were identified and enrolled in the study as a convenience sample. Cull cows were identified for fecal sampling once during each season between 2014 and 2015, specifically during spring, summer, fall, and winter, and 10 cows were randomly selected for fecal sampling at the day of their sale. In addition, study personnel completed a survey based on responses of the herd manager to questions related to the previous four month’s herd management. Fecal samples were frozen until testing for Salmonella. After overnight enrichment in liquid broth, pools of enrichment broth (EBP) were created for 5 and 10 samples. All individual and pooled broths were cultured on selective media with putative Salmonella colonies confirmed by biochemical testing before being serogrouped and serotyped. Results A total of 249 cull cows were enrolled into the study and their fecal samples tested for Salmonella. The survey-weighted period prevalence of fecal shedding of all Salmonella sp. in the cull cow samples across all study herds and the entire study period was 3.42% (N = 249; SE 1.07). The within herd prevalence of Salmonella shed in feces did not differ over the four study seasons (P = 0.074). The Se of culture of EBP of five samples was 62.5% (SE = 17.12), which was not statistically different from the Se of culture of EBP of 10 (37.5%, SE = 17.12, P = 0.48). The Sp of culture of EBP of five samples was 95.24% (SE = 3.29) and for pools of 10 samples was 100.00% (SE = 0). There was no statistical difference

Epidemiology of Salmonella sp. in California cull dairy cattle: prevalence of fecal shedding and diagnostic accuracy of pooled enriched broth culture of fecal samples.

PubMed

Abu Aboud, Omran A; Adaska, John M; Williams, Deniece R; Rossitto, Paul V; Champagne, John D; Lehenbauer, Terry W; Atwill, Robert; Li, Xunde; Aly, Sharif S

2016-01-01

The primary objective of this cross-sectional study was to estimate the crude, seasonal and cull-reason stratified prevalence of Salmonella fecal shedding in cull dairy cattle on seven California dairies. A secondary objective was to estimate and compare the relative sensitivity (Se) and specificity (Sp) for pools of 5 and 10 enriched broth cultures of fecal samples for Salmonella sp. detection. Seven dairy farms located in the San Joaquin Valley of California were identified and enrolled in the study as a convenience sample. Cull cows were identified for fecal sampling once during each season between 2014 and 2015, specifically during spring, summer, fall, and winter, and 10 cows were randomly selected for fecal sampling at the day of their sale. In addition, study personnel completed a survey based on responses of the herd manager to questions related to the previous four month's herd management. Fecal samples were frozen until testing for Salmonella. After overnight enrichment in liquid broth, pools of enrichment broth (EBP) were created for 5 and 10 samples. All individual and pooled broths were cultured on selective media with putative Salmonella colonies confirmed by biochemical testing before being serogrouped and serotyped. A total of 249 cull cows were enrolled into the study and their fecal samples tested for Salmonella. The survey-weighted period prevalence of fecal shedding of all Salmonella sp. in the cull cow samples across all study herds and the entire study period was 3.42% (N = 249; SE 1.07). The within herd prevalence of Salmonella shed in feces did not differ over the four study seasons (P = 0.074). The Se of culture of EBP of five samples was 62.5% (SE = 17.12), which was not statistically different from the Se of culture of EBP of 10 (37.5%, SE = 17.12, P = 0.48). The Sp of culture of EBP of five samples was 95.24% (SE = 3.29) and for pools of 10 samples was 100.00% (SE = 0). There was no statistical difference between the culture relative

Quality assurance program for molecular medicine laboratories.

PubMed

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

Antimicrobial activity of honey from the stingless bee Trigona carbonaria determined by agar diffusion, agar dilution, broth microdilution and time-kill methodology.

PubMed

Boorn, K L; Khor, Y-Y; Sweetman, E; Tan, F; Heard, T A; Hammer, K A

2010-05-01

The aim of this study was to determine the spectrum of antimicrobial activity of 11 samples of stingless bee honey compared to medicinal, table and artificial honeys. Activity was assessed by agar diffusion, agar dilution, broth microdilution and time-kill viability assays. By agar dilution, minimum inhibitory concentration (MIC) ranges were 4% to >10% (w/v) for Gram-positive bacteria, 6% to >16% (w/v) for Gram-negative bacteria and 6% to >10% (w/v) for Candida spp. By broth microdilution, all organisms with the exception of Candida albicans and Candida glabrata were inhibited at 3 log for Pseudomonas aeruginosa and <1 log for C. albicans. Similar treatment with each control honey resulted in decreases of <1 log for all organisms. Stingless bee honey has broad-spectrum antibacterial activity although activity against Candida was limited. Stingless bee honey samples varied in activity and the basis for this remains to be determined. Stingless bee honey had similar activity to medicinal honey and may therefore have a role as a medicinal agent.

Antianaerobic Antimicrobials: Spectrum and Susceptibility Testing

PubMed Central

Wexler, Hannah M.; Goldstein, Ellie J. C.

2013-01-01

SUMMARY Susceptibility testing of anaerobic bacteria recovered from selected cases can influence the choice of antimicrobial therapy. The Clinical and Laboratory Standards Institute (CLSI) has standardized many laboratory procedures, including anaerobic susceptibility testing (AST), and has published documents for AST. The standardization of testing methods by the CLSI allows comparisons of resistance trends among various laboratories. Susceptibility testing should be performed on organisms recovered from sterile body sites, those that are isolated in pure culture, or those that are clinically important and have variable or unique susceptibility patterns. Organisms that should be considered for individual isolate testing include highly virulent pathogens for which susceptibility cannot be predicted, such as Bacteroides, Prevotella, Fusobacterium, and Clostridium spp.; Bilophila wadsworthia; and Sutterella wadsworthensis. This review describes the current methods for AST in research and reference laboratories. These methods include the use of agar dilution, broth microdilution, Etest, and the spiral gradient endpoint system. The antimicrobials potentially effective against anaerobic bacteria include beta-lactams, combinations of beta-lactams and beta-lactamase inhibitors, metronidazole, chloramphenicol, clindamycin, macrolides, tetracyclines, and fluoroquinolones. The spectrum of efficacy, antimicrobial resistance mechanisms, and resistance patterns against these agents are described. PMID:23824372